Cleared Traditional

K100081 - ENTEROSCOPY OVERTUBE, MODEL 00712140

K100081 is an FDA 510(k) clearance for ENTEROSCOPY OVERTUBE, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K100081 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
90d
Days
Class 2
Risk

K100081 is an FDA 510(k) clearance for the ENTEROSCOPY OVERTUBE, MODEL 00712140. 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 April 12, 2010 after a review of 90 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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K100081

510(k) Number K100081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2010
Decision Date April 12, 2010
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FED Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K100081.
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · Boston Scientific Corp · Dec 2012
ENDOFLIP ECD
K110531 · Crospon, Ltd. · Oct 2011
RE-TRACE URETERAL ACCESS SHEATH
K102485 · Coloplast A/S · Oct 2010
COLONIC SPLINTING OVERTUBE, MODEL 00711145
K092221 · United States Endoscopy Group, Inc. · Oct 2009
FUJINON STERILE OVERTUBES
K091773 · Fujinon, Inc. · Aug 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · Boston Scientific Corp · Jun 2005