K242146
- 510(k) number
- K242146
- Device name
- BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
- Applicant
- Smith & Nephew Medical Limited GB
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2024-12-17
- Date received
- 2024-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K242146.pdf
Official FDA record: K242146
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.