SAWBLADE— 510(k) K863788

Substantially Equivalent

Tava Surgical Instruments

FDA 510(k) clearance K863788 for SAWBLADE, Substantially Equivalent on 1986-10-14. Applicant: Tava Surgical Instruments.

Clearance details

Applicant: Tava Surgical Instruments
Product code: Code GFA
Advisory panel: General, Plastic Surgery
Date received: 1986-09-26
Decision date: 1986-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, 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.