510(k) K163049
K163049 is an FDA 510(k) premarket notification submitted by Antarma Dba Golnit Sutures for the device "GOLNIT Non-Absorbable PTFE Surgical Suture". The FDA issued a decision of Substantially Equivalent on June 21, 2017. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2017
- Date Received
- November 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Device Class
- Class II
- Regulation Number
- 878.5035
- Review Panel
- SU
- Submission Type