Cleared Traditional

K902265 - FLEXIBLE SNARE

K902265 is an FDA 510(k) clearance for FLEXIBLE SNARE, manufactured by Annex Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K902265 · Annex Medical, Inc. · Gastroenterology & Urology device
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Jul 1990
Decision
67d
Days
Class 2
Risk

K902265 is an FDA 510(k) clearance for the FLEXIBLE SNARE. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 67 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 Annex Medical, Inc. devices

FDA 510(k) Submission Details - K902265

510(k) Number K902265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1990
Decision Date July 27, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDI Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K902265.
SPHINCTEROTOME
K930022 · Boston Scientific Corp · Apr 1993
SNARE FLEXIBLE
K924105 · United States Endoscopy Group, Inc. · Nov 1992
LAPAROSCOPIC SNARE
K911482 · United States Endoscopy Group, Inc. · Apr 1991
DOBBHOFF(R) POLYPECTOMY SNARE
K901322 · Biosearch Medical Products, Inc. · Jun 1990
DAVOL POLYPECTOMY SNARE
K845016 · C.R. Bard, Inc. · Jan 1985