510(k) K091018
K091018 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "ARTHREX BIOWIRE". The FDA issued a decision of Substantially Equivalent on July 30, 2010. The device falls under product code GAS (Suture, Nonabsorbable, Synthetic, Polyester), a Class II device regulated under 21 CFR 878.5000. Arthrex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2010
- Date Received
- April 9, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyester
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type