Gastroenterology, Urology FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance in Gastroenterology, Urology from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
29 clearances in the last 90 days. The same 90 days a year earlier: 37.
For contract manufacturers and test labs
Gastroenterology, Urology accounts for 29 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is KNW (Instrument, Biopsy). Contract manufacturers and test labs that work on Gastroenterology, Urology 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 |
|---|---|---|
KNW | Instrument, Biopsy | 4 |
GCJ | Laparoscope, General & Plastic Surgery | 3 |
EZL | Catheter, Retention Type, Balloon | 2 |
FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 |
NAY | System, Surgical, Computer Controlled Instrument | 2 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 30, 2026 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200) | K263592 |
| Oct 30, 2026 | Strauss Surgical USA | Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments | K263075 |
| Oct 29, 2026 | Bloom Surgical, Inc. | SWICS | K263459 |
| Oct 28, 2026 | Coloplast Corp. | Luja female | K263512 |
| Oct 27, 2026 | Teleflex Medical, LLC | OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnControl Bone Lesion Biopsy System;OnControl Power Driver | K262531 |
| Oct 19, 2026 | Fresenius Medical Care Renal Therapies Group, LLC | multiFiltratePRO System | K261203 |
| Oct 14, 2026 | Intuitive Surgical, Inc. | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System | K262455 |
| Oct 6, 2026 | Urolution Medical, Inc. | OpenFlo Urinary Catheter | K261141 |
| Oct 2, 2026 | Steris | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor | K261791 |
| Sep 25, 2026 | CapsoVision, Inc. | CapsoView (CVV); CapsoCloud (CLD) | K254230 |
| Sep 23, 2026 | BTL Industries, Inc. | BTL-299-F | K262353 |
| Sep 18, 2026 | Neptune Medical, Inc. | Pathfinder Endoscope Overtube | K262262 |
| Sep 17, 2026 | Medtronic, Inc. | Protégé EverFlex Self-expanding Peripheral Stent System | K262913 |
| Sep 15, 2026 | Calyxo, Inc. | CVAC Aspiration System | K261447 |
| Sep 10, 2026 | B.Braun Medical, Inc. | Irrigation/Urology Sets | K254111 |
| Sep 8, 2026 | Intuitive Surgical, Inc. | da Vinci Surgical System, Model IS5000 | K261823 |
| Sep 4, 2026 | Sentinel Medical Technologies, | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | K260756 |
| Sep 3, 2026 | Boston Scientific | Rezum System | K262460 |
| Sep 3, 2026 | Neptune Medical, Inc. | Triton 1 System | K260503 |
| Aug 26, 2026 | Boston Scientific Corporation | LithoVue Elite Digital Flexible Ureteroscope System | K261153 |
| Aug 19, 2026 | Nipro Technical Solutions, Incoporated | Nipro Dry Acid Concentrate Mixer | K260799 |
| Aug 14, 2026 | Bard Peripheral Vascular, Inc. | EnCor EnCompass Breast Biopsy and Tissue Removal System | K262571 |
| Aug 14, 2026 | Boehringer Laboratories, LLC | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D | K261890 |
| Aug 13, 2026 | Freyja Healthcare, LLC | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | K261139 |
| Aug 12, 2026 | Hologic, Inc. | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | K262792 |
| Aug 10, 2026 | Nova Eye, Inc. | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | K253468 |
| Aug 7, 2026 | Intuitive Surgical, Inc. | Intuitive Endoluminal Gastrointestinal System (IG1000) | K253702 |
| Aug 6, 2026 | Mozarc Medical Us, LLC | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | K253469 |
| Aug 4, 2026 | Medimetrix, LLC | Marrow Marxman | K260572 |
- Oct 30, 2026Intuitive Surgical, Inc.
da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200)
- Oct 30, 2026Strauss Surgical USA
Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
- Oct 29, 2026Bloom Surgical, Inc.
SWICS
- Oct 28, 2026Coloplast Corp.
Luja female
- Oct 27, 2026Teleflex Medical, LLC
OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnControl Bone Lesion Biopsy System;OnControl Power Driver
- Oct 19, 2026Fresenius Medical Care Renal Therapies Group, LLC
multiFiltratePRO System
- Oct 14, 2026Intuitive Surgical, Inc.
da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System
- Oct 6, 2026Urolution Medical, Inc.
OpenFlo Urinary Catheter
- Oct 2, 2026Steris
MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor
- Sep 25, 2026CapsoVision, Inc.
CapsoView (CVV); CapsoCloud (CLD)
- Sep 23, 2026BTL Industries, Inc.
BTL-299-F
- Sep 18, 2026Neptune Medical, Inc.
Pathfinder Endoscope Overtube
- Sep 17, 2026Medtronic, Inc.
Protégé EverFlex Self-expanding Peripheral Stent System
- Sep 15, 2026Calyxo, Inc.
CVAC Aspiration System
- Sep 10, 2026B.Braun Medical, Inc.
Irrigation/Urology Sets
- Sep 8, 2026Intuitive Surgical, Inc.
da Vinci Surgical System, Model IS5000
- Sep 4, 2026Sentinel Medical Technologies,
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
- Sep 3, 2026Boston Scientific
Rezum System
- Sep 3, 2026Neptune Medical, Inc.
Triton 1 System
- Aug 26, 2026Boston Scientific Corporation
LithoVue Elite Digital Flexible Ureteroscope System
- Aug 19, 2026Nipro Technical Solutions, Incoporated
Nipro Dry Acid Concentrate Mixer
- Aug 14, 2026Bard Peripheral Vascular, Inc.
EnCor EnCompass Breast Biopsy and Tissue Removal System
- Aug 14, 2026Boehringer Laboratories, LLC
52Fr ViSiGi LUX; 52Fr ViSiGi 3D
- Aug 13, 2026Freyja Healthcare, LLC
VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- Aug 12, 2026Hologic, Inc.
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
- Aug 10, 2026Nova Eye, Inc.
Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)
- Aug 7, 2026Intuitive Surgical, Inc.
Intuitive Endoluminal Gastrointestinal System (IG1000)
- Aug 6, 2026Mozarc Medical Us, LLC
Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)
- Aug 4, 2026Medimetrix, LLC
Marrow Marxman
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.
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