Cleared Traditional

K941728 - MONOPOLAR COAGULATING POLYPECTOMY SNARE

K941728 is an FDA 510(k) clearance for MONOPOLAR COAGULATING POLYPECTOMY SNARE, manufactured by Endoscopic Innovations, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K941728 · Endoscopic Innovations, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
81d
Days
Class 2
Risk

K941728 is an FDA 510(k) clearance for the MONOPOLAR COAGULATING POLYPECTOMY SNARE. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Endoscopic Innovations, Inc. (Morris, US). The FDA issued a Cleared decision on June 27, 1994 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 Endoscopic Innovations, Inc. devices

FDA 510(k) Submission Details - K941728

510(k) Number K941728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1994
Decision Date June 27, 1994
Days to Decision 81 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 130d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K941728.
AESCULAP THORACOSCOPIC INSTRUMENTS
K944955 · Aesculap, Inc. · Nov 1994
MICROVASIVE INJECTION GOLD PROBE
K942301 · Boston Scientific Corp · Nov 1994
CABOT MEDICAL BIPOLAR CUTTING FORCEPS
K932293 · Cabot Medical Corp. · Jul 1994
ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME
K934315 · Endovations · Feb 1994
DOBBHOFF BIPOLAR ADAPTER
K921029 · Biosearch Medical Products, Inc. · May 1992
BIPOLAR ENDOSTASIS PROBE, BEST (TM)
K915408 · Medical Devices, Inc. · Mar 1992