K253204
- 510(k) number
- K253204
- Device name
- Catalyze
- Applicant
- BioTissue Holdings, Inc. FL · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2026-06-05
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K253204.pdf
Official FDA record: K253204
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.