510(k) K060165
K060165 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "AXYAFLEX POLYESTER SUTURE". The FDA issued a decision of Substantially Equivalent on September 1, 2006. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2006
- Date Received
- January 23, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type