510(k) K113763
K113763 is an FDA 510(k) premarket notification submitted by Nobles Medical Technologies Ii, Inc. for the device "SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on March 16, 2012. 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
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2012
- Date Received
- December 21, 2011
- Clearance Type
- Special
- 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