510(k) K220091
K220091 is an FDA 510(k) premarket notification submitted by Xiros, Ltd. for the device "Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device". The FDA issued a decision of Substantially Equivalent on August 26, 2022. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Xiros, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2022
- Date Received
- January 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type