Cleared Traditional

K940335 - AMERICAN CATHETER POLY-SNARE

K940335 is an FDA 510(k) clearance for AMERICAN CATHETER POLY-SNARE, manufactured by Intl. Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K940335 · Intl. Medical, Inc. · Gastroenterology & Urology device
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Jul 1994
Decision
177d
Days
Class 2
Risk

K940335 is an FDA 510(k) clearance for the AMERICAN CATHETER POLY-SNARE. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Fort Myers, US). The FDA issued a Cleared decision on July 21, 1994 after a review of 177 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Medical, Inc. devices

FDA 510(k) Submission Details - K940335

510(k) Number K940335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1994
Decision Date July 21, 1994
Days to Decision 177 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 131d · This submission: 177d
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 49
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K940335.
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K950496 · Boston Scientific Corp · Mar 1995
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
K941750 · Boston Scientific Corp · Nov 1994
INJECT-SNARE
K942110 · Endovations · Oct 1994
ENDOSNARE
K923031 · Cook Urological, Inc. · Jun 1993
SPHINCTEROTOME
K930022 · Boston Scientific Corp · Apr 1993
SNARE FLEXIBLE
K924105 · United States Endoscopy Group, Inc. · Nov 1992