SAPHLIFT— 510(k) K990062

Substantially Equivalent

Genzyme Surgical Product (Genzyme Biosurgery)

FDA 510(k) clearance K990062 for SAPHLIFT, Substantially Equivalent on 1999-03-30. Applicant: Genzyme Surgical Product (Genzyme Biosurgery).

Clearance details

Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
Product code: Code MDM
Advisory panel: General, Plastic Surgery
Date received: 1999-01-08
Decision date: 1999-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.