Cleared Traditional

K962676 - DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE

K962676 is an FDA 510(k) clearance for DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K962676 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
87d
Days
Class 2
Risk

K962676 is an FDA 510(k) clearance for the DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE. Classified as Dislodger, Stone, Flexible (product code FGO), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on October 4, 1996 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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

FDA 510(k) Submission Details - K962676

510(k) Number K962676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1996
Decision Date October 04, 1996
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGO Device Classification - Class 2, Special Controls

Product Code FGO Dislodger, Stone, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 - FGO Dislodger, Stone, Flexible

All 12
Devices cleared under the same product code (FGO) and FDA review panel - the closest regulatory comparables to K962676.
STONE DISLODGER, BASKET
K970121 · Boston Scientific Corp · Apr 1997
RETRIEVAL SNARE
K963750 · Boston Scientific Corp · Nov 1996
STONE DISLODGER, BASKET
K951309 · Boston Scientific Corp · May 1995
GRASPING FORCEPS
K933261 · Surgitek · Jan 1994
GRASPING FORCEPS OR RETRIEVAL FORCEPS
K934598 · Annex Medical, Inc. · Jan 1994
INTRAVENOUS CATHETERS MODIFICATIONS
K921295 · Critikon Company, LLC · May 1993