510(k) K212579
K212579 is an FDA 510(k) premarket notification submitted by Organogenesis, Inc. for the device "FortiShield (Biosynthetic Wound Matrix)". The FDA issued a decision of Substantially Equivalent on May 2, 2023. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Organogenesis, Inc. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2023
- Date Received
- Aug 16, 2021
- 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
- Review Panel
- SU
- Submission Type
- 510(k)