General, Plastic Surgery FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance in General, Plastic Surgery from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
See the Contacts for these companies. Start your free month.
For medtech business development and sales professionals at firms that sell services to medical device companies. Whimbrel saves you hours of research on medical device companies, inside the AI app you already use, like ChatGPT or Claude.
Last 90 days
28 clearances in the last 90 days. The same 90 days a year earlier: 32.
For contract manufacturers and test labs
General, Plastic Surgery accounts for 28 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is GEI (Electrosurgical, Cutting & Coagulation & Accessories). Contract manufacturers and test labs that work on General, Plastic Surgery devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 |
GEH | Unit, Cryosurgical, Accessories | 2 |
GEX | Powered Laser Surgical Instrument | 2 |
SAH | Magnetic Compression Anastomosis System | 2 |
FTL | Mesh, Surgical, Polymeric | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 30, 2026 | Borze, Inc. | B`orze Inc Laser Family (Sorren/Adonis) | K263063 |
| Oct 28, 2026 | Fziomed, Inc. | Dynavisc | K262343 |
| Oct 28, 2026 | GI Windows Surgical | GI Windows Flexagon Plus OTOLoc System | K261630 |
| Oct 28, 2026 | O&M Halyard, Inc. | HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL) | K260310 |
| Oct 27, 2026 | Smith & Nephew, Inc. | Tendon Anchor | K263461 |
| Oct 27, 2026 | Cryoconcepts LP | Skin Clinic Nitro Clear for Warts and Skin Tags | K260520 |
| Oct 26, 2026 | Single Pass, Inc. | SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max) | K262720 |
| Oct 21, 2026 | AtriCure, Inc. | ACHM30 AtriClip FLEX-Mini LAA Exclusion System | K263319 |
| Oct 20, 2026 | Stryker Instruments | SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) | K262386 |
| Sep 29, 2026 | Riverpoint Medical, LLC | Fast Absorbing PGLA | K263073 |
| Sep 28, 2026 | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | Phasix ST Parastomal Hernia Mesh | K261543 |
| Sep 28, 2026 | TELA Bio, Inc. | Liora Monofilament Scaffold | K260474 |
| Sep 22, 2026 | Bh Group Us, LLC | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | K243223 |
| Sep 18, 2026 | VacHeal, LLC | VacHeal Negative Pressure Wound Therapy System | K254160 |
| Sep 17, 2026 | Stryker Instruments | Neptune SafeAir 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune SafeAir 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune SafeAir 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune SafeAir 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | K261959 |
| Sep 17, 2026 | Ethicon Endo-Surgery, LLC | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | K254196 |
| Sep 16, 2026 | Olympus Surgical Technologies America | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | K262877 |
| Sep 16, 2026 | Gt Metabolic Solutions, Inc. | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | K261467 |
| Sep 15, 2026 | Covidien, LLC | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | K261070 |
| Sep 3, 2026 | Monteris Medical | NeuroBlate System | K262315 |
| Sep 2, 2026 | Serpex Medical | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | K262420 |
| Sep 2, 2026 | Ellian Corp | Ellian Enigma RF Device | K262364 |
| Aug 21, 2026 | Apyx Medical Corporation | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors | K261710 |
| Aug 20, 2026 | Virtual Incision | MIRA Surgical System | K260817 |
| Aug 18, 2026 | Theramicro | TeKBrace Solo Soft Tissue Reinforcement Device | K262729 |
| Aug 12, 2026 | Boston Scientific | EluPro Antibiotic-Eluting BioEnvelope | K262406 |
| Aug 11, 2026 | PolyConversions, Inc. | VR Personal Protective Level 4 Gown (VR Gowns) | K261115 |
| Aug 3, 2026 | 3-D Matrix, Inc. | PuraStat GI | K261503 |
- Oct 30, 2026Borze, Inc.
B`orze Inc Laser Family (Sorren/Adonis)
- Oct 28, 2026Fziomed, Inc.
Dynavisc
- Oct 28, 2026GI Windows Surgical
GI Windows Flexagon Plus OTOLoc System
- Oct 28, 2026O&M Halyard, Inc.
HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
- Oct 27, 2026Smith & Nephew, Inc.
Tendon Anchor
- Oct 27, 2026Cryoconcepts LP
Skin Clinic Nitro Clear for Warts and Skin Tags
- Oct 26, 2026Single Pass, Inc.
SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max)
- Oct 21, 2026AtriCure, Inc.
ACHM30 AtriClip FLEX-Mini LAA Exclusion System
- Oct 20, 2026Stryker Instruments
SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000)
- Sep 29, 2026Riverpoint Medical, LLC
Fast Absorbing PGLA
- Sep 28, 2026Davol, Inc., A Subsidiary of C.R. Bard, Inc.
Phasix ST Parastomal Hernia Mesh
- Sep 28, 2026TELA Bio, Inc.
Liora Monofilament Scaffold
- Sep 22, 2026Bh Group Us, LLC
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
- Sep 18, 2026VacHeal, LLC
VacHeal Negative Pressure Wound Therapy System
- Sep 17, 2026Stryker Instruments
Neptune SafeAir 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune SafeAir 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune SafeAir 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune SafeAir 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)
- Sep 17, 2026Ethicon Endo-Surgery, LLC
HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- Sep 16, 2026Olympus Surgical Technologies America
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- Sep 16, 2026Gt Metabolic Solutions, Inc.
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)
- Sep 15, 2026Covidien, LLC
LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
- Sep 3, 2026Monteris Medical
NeuroBlate System
- Sep 2, 2026Serpex Medical
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- Sep 2, 2026Ellian Corp
Ellian Enigma RF Device
- Aug 21, 2026Apyx Medical Corporation
AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors
- Aug 20, 2026Virtual Incision
MIRA Surgical System
- Aug 18, 2026Theramicro
TeKBrace Solo Soft Tissue Reinforcement Device
- Aug 12, 2026Boston Scientific
EluPro Antibiotic-Eluting BioEnvelope
- Aug 11, 2026PolyConversions, Inc.
VR Personal Protective Level 4 Gown (VR Gowns)
- Aug 3, 20263-D Matrix, Inc.
PuraStat GI
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
FAQ
More signal searches
See the Contacts for these companies
Start your free month, then ask inside the AI app you already use.