Gastroenterology, Urology— FDA advisory panel GU
11,279 FDA 510(k) clearances across 401 product codes since 1976.
By Andrew Weston — Installation Systems Engineer
A two-specialty panel joined by shared tooling: flexible and rigid endoscopes and their accessories, urological catheters, ureteral stents, lithotripsy systems, hemodialysis machines and dialyzers, bowel-management devices, and endoscopic therapeutic instruments (snares, clips, dilation balloons). Its high product-code count comes from the accessory ecosystems — every scope family drags a constellation of cleared accessories behind it.
Hemodialysis is the quiet heavyweight here: dialyzers, dialysate concentrates, and delivery systems all clear through this panel, and that equipment sits under sustained regulatory attention because of its direct-life-support role. On the GI side, watch the endoscopy accessory codes for the single-use trend — reusable-scope infection concerns have pushed a visible wave of disposable-instrument clearances in recent years.
Clearances per year
last 10 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
Top product codes in the Gastroenterology, Urology panel
all codes- GCJ — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
- KNT — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)
- FGE — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
- KNW — Promisemed VeriEcto Automatic Biopsy Needles
- KDI — Careflux H60;Careflux H70;Careflux V500
- KOD — Rubber Utility Catheter
- KNX — IBAG
- KNS — Sphincterotome
- KOC — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
- NAY — OTTAVA Robotic Surgical System
- FCG — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
- FJI — Hemoflow F3 and F4 Dialyzers
- EZL — Rusch SoftSimplastic Foley Catheters
- MSD — Hemodialysis Catheter
- KPO — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
Recent clearances in the Gastroenterology, Urology panel
all clearances- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
- K254180 — PerfusiX-Imaging
- K261267 — Careflux H60;Careflux H70;Careflux V500
- K261274 — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
- K262152 — VS-370CF, VS-370CT
- K261644 — Perfadex Plus
- DEN250068 — OTTAVA Robotic Surgical System
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
- K261573 — ENDOSCOPE HOLDER (182214)
- K261614 — LED LCD Monitor (OEV-271H)
Data sourced from openFDA. This site is unofficial and independent of the FDA.