Cleared Traditional

K221177 - Erbe's Tubing/Cap Sets (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221177 · Erbe USA, Inc. · Gastroenterology & Urology device
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Aug 2022
Decision
108d
Days
Class 2
Risk

K221177 is an FDA 510(k) clearance for the Erbe's Tubing/Cap Sets. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on August 11, 2022 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Erbe USA, Inc. devices

Submission Details

510(k) Number K221177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date August 11, 2022
Days to Decision 108 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 130d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 92
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K221177.
AUXILIARY WATER TUBE MAJ-855
K251986 · Olympus Medical Systems Corporation · Sep 2025
Single-Use Biopsy Valve (MAJ-1555)
K251997 · Olympus Medical Systems Corporation · Sep 2025
ArgoCap (200.52)
K242586 · Ovesco Endoscopy AG · May 2025
Endoscopic Water Pump
K241704 · Hangzhou AGS MedTech Co., Ltd. · Mar 2025
Water Container (MAJ-901)
K242357 · Olympus Medical Systems Corporation · Oct 2024
Aspiration Catheter (2189)
K241874 · Hobbs Medical, Inc. · Sep 2024