Cleared Traditional

K040836 - DISPOSABLE OVERTUBE

K040836 is the FDA 510(k) clearance for DISPOSABLE OVERTUBE by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FED) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K040836 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Jun 2004
Decision
71d
Days
Class 2
Risk

K040836 is an FDA 510(k) clearance for the DISPOSABLE OVERTUBE. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K040836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2004
Decision Date June 10, 2004
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 60
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K040836.
COLONIC SPLINTING OVERTUBE, MODEL 00711145
K092221 · United States Endoscopy Group, Inc. · Oct 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · Boston Scientific Corp · Jun 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K043418 · Cook Urological, Inc. · Mar 2005
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
K033778 · C.R. Bard, Inc. · Dec 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
K030956 · Boston Scientific Corp · May 2003
BARD AQUAGUIDE URETERAL CONDUIT
K030438 · C.R. Bard, Inc. · Mar 2003