Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter— 510(k) K173105

Name: FDA 510(k) clearance K173105
Creator: U.S. Food and Drug Administration
Published: 2018-03-22

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K173105 for Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter, Substantially Equivalent on 2018-03-22. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2017-09-29
Decision date: 2018-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODC

view all

K252933 — DYNE PORT2026-06-12
K250145 — Biopsy Port Adapter2025-10-17
K252910 — Orca Air/Water and Suction Valves2025-10-09
K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)2025-07-16
K250732 — Disposable Endoscopy Valve Set2025-06-20

More clearances from Cook Incorporated

view all

K233177 — Nest VT Vitrification Device2024-03-08
K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
K223098 — Bakri Essential Postpartum Balloon2022-10-28
K210734 — Endovascular Dilator and Sets2021-04-06
K203670 — Extra Large Check-Flo Introducer2021-02-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.