HERNIASTAT— 510(k) K884404

Substantially Equivalent

Innovative Surgical Devices Corp.

FDA 510(k) clearance K884404 for HERNIASTAT, Substantially Equivalent on 1988-11-08. Applicant: Innovative Surgical Devices Corp..

Clearance details

Applicant: Innovative Surgical Devices Corp.
Product code: Code GAG
Advisory panel: General Hospital
Date received: 1988-10-19
Decision date: 1988-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbury, NY, US

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Adverse events under product code GAG

product code GAG

Death: 23
Injury: 394
Malfunction: 2,304
Other: 6
Total: 2,727

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.