RETRACTOR ARM CLAMP— 510(k) K960019

Substantially Equivalent

Biopsys Medical, Inc.

FDA 510(k) clearance K960019 for RETRACTOR ARM CLAMP, Substantially Equivalent on 1996-02-09. Applicant: Biopsys Medical, Inc..

Clearance details

Applicant: Biopsys Medical, Inc.
Product code: Code FWZ
Advisory panel: General, Plastic Surgery
Date received: 1996-01-02
Decision date: 1996-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.