Cleared Traditional

K941750 - PROPOSED TRADEMAN MICROVASIVE POLYPECTO...

K941750 is the FDA 510(k) clearance for PROPOSED TRADEMAN MICROVASIVE POLYPECTO... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K941750 · Boston Scientific Corp · Gastroenterology & Urology device
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Nov 1994
Decision
207d
Days
Class 2
Risk

K941750 is an FDA 510(k) clearance for the PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on November 1, 1994 after a review of 207 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 Boston Scientific Corp devices

Submission Details

510(k) Number K941750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1994
Decision Date November 01, 1994
Days to Decision 207 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 slower than avg
Panel avg: 130d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K941750.
OLYMPUS SD SERIES SNARES
K955650 · Olympus America, Inc. · Mar 1996
MILL-ROSE ROTATABLE POLYPECTOMY SNARE
K951600 · Mill-Rose Laboratory · Dec 1995
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K950496 · Boston Scientific Corp · Mar 1995
INJECT-SNARE
K942110 · Endovations · Oct 1994
ENDOSNARE
K923031 · Cook Urological, Inc. · Jun 1993
SPHINCTEROTOME
K930022 · Boston Scientific Corp · Apr 1993