510(k) K123877

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN by Surgical Specialties Corp. Dba Angiotech — Product Code NEW

K123877 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp. Dba Angiotech for the device "QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN". The FDA issued a decision of Substantially Equivalent on January 2, 2013. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Surgical Specialties Corp. Dba Angiotech has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2013
Date Received
December 17, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type