510(k) K011027
K011027 is an FDA 510(k) premarket notification submitted by Organogenesis, Inc. for the device "FORTAFLEX SURGICAL SLING". The FDA issued a decision of Substantially Equivalent on May 30, 2001. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Organogenesis, Inc. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2001
- Date Received
- Apr 5, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
- 510(k)