Gastroenterology, Urology— FDA advisory panel GU
11,324 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 — CuratOR EX2742
- KNT — 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®
- FGE — ARCHIMEDES Biodegradable Stent (Medium)
- KNW — Automatic Core Biopsy Instrument
- KDI — Careflux H60; Careflux H70; Careflux V500
- 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 Surgical System, Model IS5000
- FCG — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- FJI — Hemoflow F3 and F4 Dialyzers
- EZL — TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
- MSD — Hemodialysis Catheter
- KPO — Nipro Dry Acid Concentrate Mixer
Recent clearances in the Gastroenterology, Urology panel
all clearances- K260133 — CADDIE
- K260410 — Single Use Ureteral Access Sheath
- K262397 — CuratOR EX2742
- K254111 — Irrigation/Urology Sets
- K260110 — danumed Extension Set for Gastrostomy Button
- K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB
- K260997 — SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01)
- K261470 — PurGuard360(QF10)
- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K261823 — da Vinci Surgical System, Model IS5000
Data sourced from openFDA. This site is unofficial and independent of the FDA.