Cleared Traditional

K962653 - MICROGYN RESECTION LOOP

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
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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
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 130d · 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 29
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K962653.
AMS COAGULOOP RESECTION ELECTRODE
K971512 · American Medical Systems, Inc. · Jul 1997
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K970526 · Arthrocare Corp. · May 1997
VAPOR-TECH SLED ELECTRODE
K970717 · Northgate Technologies, Inc. · May 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