Cleared Traditional

K970356 - IRRIGATION/ASPIRATION POLYPECTOMY

K970356 is an FDA 510(k) clearance for IRRIGATION/ASPIRATION POLYPECTOMY, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K970356 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
54d
Days
Class 2
Risk

K970356 is an FDA 510(k) clearance for the IRRIGATION/ASPIRATION POLYPECTOMY. 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 March 25, 1997 after a review of 54 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

FDA 510(k) Submission Details - K970356

510(k) Number K970356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1997
Decision Date March 25, 1997
Days to Decision 54 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
77d faster than avg
Panel avg: 131d · This submission: 54d
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 51
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K970356.
INJECTOR NEEDLE/SNARE
K040961 · United States Endoscopy Group, Inc. · Jul 2004
ROTOSNARE
K992477 · Inscope, LLC · Aug 1999
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
K971275 · Mill-Rose Laboratory · May 1997
SNARE
K960230 · Lighthouse Medical, Inc. · Jul 1996
OLYMPUS SD SERIES SNARES
K955650 · Olympus America, Inc. · Mar 1996
MILL-ROSE ROTATABLE POLYPECTOMY SNARE
K951600 · Mill-Rose Laboratory · Dec 1995