MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT— 510(k) K962653

Substantially Equivalent

Microgyn Corp.

FDA 510(k) clearance K962653 for MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT, Substantially Equivalent on 1997-02-04. Applicant: Microgyn Corp..

Clearance details

Applicant: Microgyn Corp.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1996-07-08
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, MA, US

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Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.