DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS— 510(k) K953012

Substantially Equivalent

Boston Surgical Products, Inc.

FDA 510(k) clearance K953012 for DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS, Substantially Equivalent on 1995-07-12. Applicant: Boston Surgical Products, Inc..

Clearance details

Applicant: Boston Surgical Products, Inc.
Product code: Code GFA
Advisory panel: General, Plastic Surgery
Date received: 1995-06-28
Decision date: 1995-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.