Cleared Traditional

K091355 - DEUCE POLYPECTOMY SNARE

K091355 is an FDA 510(k) clearance for DEUCE POLYPECTOMY SNARE, manufactured by Conmed Endoscopic Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K091355 · Conmed Endoscopic Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
75d
Days
Class 2
Risk

K091355 is an FDA 510(k) clearance for the DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Conmed Endoscopic Technologies, Inc. (Chelmsford, US). The FDA issued a Cleared decision on July 22, 2009 after a review of 75 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 Conmed Endoscopic Technologies, Inc. devices

FDA 510(k) Submission Details - K091355

510(k) Number K091355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date July 22, 2009
Days to Decision 75 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 130d · This submission: 75d
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 K091355.
EC SINGLE USE, POLYPECTOMY SNARE
K123223 · Endochoice, Inc. · Jan 2013
ROTH NET RETRIEVER
K122462 · United States Endoscopy Group, Inc. · Sep 2012
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
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ETHICON ENDO SURGERY ARTICULATING SNARE
K073288 · Ethicon Endo-Surgery, Inc. · Jun 2008
COOK IRELAND SONNET POLYPECTOMY SNARE
K050294 · Cook Ireland, Ltd. · Mar 2005
INJECTOR NEEDLE/SNARE
K040961 · United States Endoscopy Group, Inc. · Jul 2004