GalaFLEX LITE Scaffold— 510(k) K233999
Substantially EquivalentTepha, Inc.
FDA 510(k) clearance K233999 for GalaFLEX LITE Scaffold, Substantially Equivalent on 2024-04-09. Applicant: Tepha, Inc.. Device class: 2.
Clearance details
- Applicant
- Tepha, Inc.
- Product code
- Code OOD
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Recent devices under product code OOD
view allMore clearances from Tepha, Inc.
view allAdverse events under product code OOD
product code OOD- Death
- 6
- Injury
- 1,005
- Total
- 1,011
Source: openFDA MAUDE database, through . 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.