ISI SELF-SUPPORTING ARM— 510(k) K925005

Substantially Equivalent

Instrumentation Specialties, Inc.

FDA 510(k) clearance K925005 for ISI SELF-SUPPORTING ARM, Substantially Equivalent on 1993-04-29. Applicant: Instrumentation Specialties, Inc..

Clearance details

Applicant: Instrumentation Specialties, Inc.
Product code: Code BWN
Advisory panel: General, Plastic Surgery
Date received: 1992-10-02
Decision date: 1993-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boerne, TX, US

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Adverse events under product code BWN

product code BWN

Other: 1
Total: 1

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.