510(k) K023372
K023372 is an FDA 510(k) premarket notification submitted by Onux Medical, Inc. for the device "NON-BIOABSORBABLE STAPLE". The FDA issued a decision of Substantially Equivalent on December 27, 2002. The device falls under product code NJU (Suture, Nonabsorbable, Nitinol), a Class II device regulated under 21 CFR 878.4495. Onux Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2002
- Date Received
- October 8, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Nitinol
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type
Soft tissue approximation.