510(k) K113494

NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA by Nobles Medical Technologies Ii, Inc. — Product Code GAW

K113494 is an FDA 510(k) premarket notification submitted by Nobles Medical Technologies Ii, Inc. for the device "NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA". The FDA issued a decision of Substantially Equivalent on April 19, 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
April 19, 2012
Date Received
November 25, 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