Cleared Traditional

K962653 - MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT

K962653 is an FDA 510(k) clearance for MICROGYN RESECTION LOOP, manufactured by Microgyn Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K962653 · Microgyn Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
211d
Days
Class 2
Risk

K962653 is an FDA 510(k) clearance for the MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP E.... Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Microgyn Corp. (Taunton, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 211 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 Microgyn Corp. devices

FDA 510(k) Submission Details - K962653

510(k) Number K962653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1996
Decision Date February 04, 1997
Days to Decision 211 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
80d slower than avg
Panel avg: 131d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

Product Code FAS Electrode, Electrosurgical, Active, Urological
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 - FAS Electrode, Electrosurgical, Active, Urological

All 47
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K962653.
RESECTOSCOPE CUTTING LOOP ELECTRODE
K964365 · Omnitech Systems, Inc. · Apr 1997
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K965093 · Omnitech Systems, Inc. · Mar 1997
ENDOCARE MONOPOLAR ELECTRODE
K965118 · Endocare, Inc. · Feb 1997
BARD COAGULATING RESECTOR MODEL (3552XX
K962538 · C.R. Bard, Inc. · Dec 1996
BARD V-MAX ROLLER BAR (3551XX
K961841 · C.R. Bard, Inc. · Oct 1996
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
K953983 · Richard Wolf Medical Instruments Corp. · Oct 1996