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FDA PRODUCT CODE · CLASS II

OCX — Endoscopic Irrigation/Suction System

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K251986Olympus Medical Systems Corporation · 510k2025-09-26
K251997Olympus Medical Systems Corporation · 510k2025-09-25
K242586Ovesco Endoscopy AG · 510k2025-05-22
K241704Hangzhou AGS MedTech Co., Ltd. · 510k2025-03-20
K242357Olympus Medical Systems Corporation · 510k2024-10-07
K241874Hobbs Medical, Inc. · 510k2024-09-24

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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