GalaFLEX LITE Scaffold— 510(k) K233999

Substantially Equivalent

Tepha, Inc.

FDA 510(k) clearance K233999 for GalaFLEX LITE Scaffold, Substantially Equivalent on 2024-04-09. Applicant: Tepha, Inc..

Clearance details

Applicant: Tepha, Inc.
Product code: Code OOD
Advisory panel: General, Plastic Surgery
Date received: 2023-12-18
Decision date: 2024-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OOD

product code OOD

Death: 6
Injury: 1,005
Total: 1,011

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.