510(k) K052373

QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE by Quill Medical, Inc. — Product Code GAW

K052373 is an FDA 510(k) premarket notification submitted by Quill Medical, Inc. for the device "QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE". The FDA issued a decision of Substantially Equivalent on September 26, 2005. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Quill Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2005
Date Received
August 30, 2005
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