SEAL SINGLE-USE BIOPSY VALVE— 510(k) K133734

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K133734 for SEAL SINGLE-USE BIOPSY VALVE, Substantially Equivalent on 2014-03-19. Applicant: Endochoice, Inc.. Device class: 2.

Clearance details

Applicant: Endochoice, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2013-12-09
Decision date: 2014-03-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OCX

K251986 — AUXILIARY WATER TUBE MAJ-8552025-09-26
K251997 — Single-Use Biopsy Valve (MAJ-1555)2025-09-25
K242586 — ArgoCap (200.52)2025-05-22
K241704 — Endoscopic Water Pump2025-03-20
K242357 — Water Container (MAJ-901); Water Container (MAJ-902)2024-10-07

More clearances from Endochoice, Inc.

K160275 — Fuse Endoscopic System with FuseBox Processor2016-08-01
K161482 — EndoChoice Water Bottle Cap Irrigation System2016-06-27
K161167 — Seal Single-Use Biopsy Valve2016-05-26
K160403 — SmartStart Air/Water and Suction Valves2016-05-19
K153588 — EndoChoice Water Bottle Cap System2016-02-24

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