UNI-THANE— 510(k) K831611

Substantially Equivalent

Carapac Systems, Inc.

FDA 510(k) clearance K831611 for UNI-THANE, Substantially Equivalent on 1983-06-20. Applicant: Carapac Systems, Inc..

Clearance details

Applicant: Carapac Systems, Inc.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1983-05-19
Decision date: 1983-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.