Gastroenterology, Urology— FDA advisory panel GU
11,355 FDA 510(k) clearances across 402 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 — SWICS
- KNT — danumed StomaMeter
- FGE — Drainage Catheter
- KNW — OnControl Powered Bone Access Systems +4 more
- KDI — multiFiltratePRO System
- KOD — Rubber Utility Catheter
- KNX — IBAG
- KNS — Rezum System
- 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 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- FCG — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- FJI — Hemoflow F3 and F4 Dialyzers
- EZL — OpenFlo Urinary Catheter
- MSD — Hemodialysis Catheter
- KPO — Nipro Dry Acid Concentrate Mixer
Recent clearances in the Gastroenterology, Urology panel
all clearances- K263075 — Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
- K263592 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- K262437 — Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)
- K263459 — SWICS
- K263512 — Luja female
- K262531 — OnControl Powered Bone Access Systems +4 more
- K260350 — Cysto-Urethroscopes and accessories
- K261670 — Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ) +5 more
- K260708 — Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection) +1 more
- K261203 — multiFiltratePRO System
Data sourced from openFDA. This site is unofficial and independent of the FDA.