MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT— 510(k) K962653
Substantially EquivalentMicrogyn 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.. Device class: 2.
Clearance details
- Applicant
- Microgyn Corp.
- Product code
- Code FAS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- 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, through . 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.