Cleared Traditional

K221177 - Erbe's Tubing/Cap Sets

K221177 is the FDA 510(k) clearance for Erbe's Tubing/Cap Sets by Erbe USA, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCX) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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 58
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K221177.
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
K221310 · Changzhou Endoclean Medical Device Co., Ltd. · Oct 2022
Clean Connecting Tube
K220785 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Sep 2022
OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315
K221824 · Cipher Surgical Limited · Aug 2022
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
K210618 · Chongqing Jinshan Science & Technology Co., Ltd. · Oct 2021
ENDOtube
K203350 · Nissha Medical Technologies Sas · Sep 2021
ClearCap Distal Attachment
K202616 · Finemedix Co., Ltd. · Feb 2021