ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR— 510(k) K853114

Substantially Equivalent

Australian Biomedical Corporation , Ltd.

FDA 510(k) clearance K853114 for ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR, Substantially Equivalent on 1985-08-06. Applicant: Australian Biomedical Corporation , Ltd..

Clearance details

Applicant: Australian Biomedical Corporation , Ltd.
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1985-07-24
Decision date: 1985-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.