Cleared Traditional

K911482 - LAPAROSCOPIC SNARE

K911482 is the FDA 510(k) clearance for LAPAROSCOPIC SNARE by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K911482 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Apr 1991
Decision
18d
Days
Class 2
Risk

K911482 is an FDA 510(k) clearance for the LAPAROSCOPIC SNARE. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on April 22, 1991 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 K911482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date April 22, 1991
Days to Decision 18 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 130d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDI Snare, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - FDI Snare, Flexible

All 36
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K911482.
ENDOSNARE
K923031 · Cook Urological, Inc. · Jun 1993
SPHINCTEROTOME
K930022 · Boston Scientific Corp · Apr 1993
SNARE FLEXIBLE
K924105 · United States Endoscopy Group, Inc. · Nov 1992
DOBBHOFF(R) POLYPECTOMY SNARE
K901322 · Biosearch Medical Products, Inc. · Jun 1990
DAVOL POLYPECTOMY SNARE
K845016 · C.R. Bard, Inc. · Jan 1985