Cleared Traditional

K002927 - SNARE,FLEXIBLE

K002927 is an FDA 510(k) clearance for SNARE, manufactured by Odon Lifetechnology. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K002927 · Odon Lifetechnology · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
81d
Days
Class 2
Risk

K002927 is an FDA 510(k) clearance for the SNARE,FLEXIBLE. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Odon Lifetechnology (Neuilly Sur Seine, FR). The FDA issued a Cleared decision on December 10, 2000 after a review of 81 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 Odon Lifetechnology devices

FDA 510(k) Submission Details - K002927

510(k) Number K002927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2000
Decision Date December 10, 2000
Days to Decision 81 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
50d faster than avg
Panel avg: 131d · This submission: 81d
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 61
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K002927.
HORIZONS REUSABLE POLYPECTOMY SNARES
K022268 · Horizons Intl. Corp. · Oct 2002
NAKAO SNARE II AND NAKAO SNARE III
K020891 · Granit Medical Innovations · Jun 2002
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
K011667 · Horizons Intl. Corp. · Aug 2001
ROTOSNARE
K992477 · Inscope, LLC · Aug 1999
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
K971275 · Mill-Rose Laboratory · May 1997
IRRIGATION/ASPIRATION POLYPECTOMY
K970356 · United States Endoscopy Group, Inc. · Mar 1997