SCUBA SYSTEM— 510(k) K962482

Substantially Equivalent

Gynecare, Inc.

FDA 510(k) clearance K962482 for SCUBA SYSTEM, Substantially Equivalent on 1996-11-01. Applicant: Gynecare, Inc..

Clearance details

Applicant: Gynecare, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1996-06-26
Decision date: 1996-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.