Cleared Traditional

K103696 - ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET...

K103696 is the FDA 510(k) clearance for ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET... by Erbe USA, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FEQ) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K103696 · Erbe USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
95d
Days
Class 2
Risk

K103696 is an FDA 510(k) clearance for the ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIE.... Classified as Pump, Air, Non-manual, For Endoscope (product code FEQ), Class II - Special Controls.

Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on March 22, 2011 after a review of 95 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 K103696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2010
Decision Date March 22, 2011
Days to Decision 95 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
35d faster than avg
Panel avg: 130d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEQ Pump, Air, Non-manual, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FEQ Pump, Air, Non-manual, For Endoscope

All 9
Devices cleared under the same product code (FEQ) and FDA review panel - the closest regulatory comparables to K103696.
AquaShield system CO2, AquaShield system-PENTAX
K153362 · United States Endoscopy Group, Inc. · Dec 2015
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
K132340 · Erbe USA, Inc. · Dec 2013
AQUASHIELD CO2 SYSTEM
K120123 · United States Endoscopy Group, Inc. · Mar 2012
WATER BOTTLE CAP SYSTEM
K101146 · United States Endoscopy Group, Inc. · Jul 2010