510(k) K233378
K233378 is an FDA 510(k) premarket notification submitted by Acro Biomedical Co., Ltd. for the device "ABCcolla® Collagen ADM Scaffold". The FDA issued a decision of Substantially Equivalent on October 18, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Acro Biomedical Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2024
- Date Received
- October 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type