510(k) K162617
K162617 is an FDA 510(k) premarket notification submitted by Nobles Medical Technologies Ii, Inc. for the device "NobleStitch EL". The FDA issued a decision of SESU on April 6, 2017. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Nobles Medical Technologies Ii, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- April 6, 2017
- Date Received
- September 20, 2016
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Device Class
- Class II
- Regulation Number
- 878.5010
- Review Panel
- SU
- Submission Type