QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Suture, Surgical, Absorbable, Polydioxanone

SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

The following data is part of a premarket notification filed by Surgical Specialties Corp. Dba Angiotech with the FDA for Quill Pdo Knotless Tissue-closure Device, Variable Loop Design.

Pre-market Notification Details

• Device ID: K123877
• 510k Number: K123877
• Device Name: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
• Classification: Suture, Surgical, Absorbable, Polydioxanone
• Applicant: SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading, PA 19606
• Contact: Kirsten Stowell
• Correspondent: Kirsten Stowell; SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading, PA 19606
• Product Code: NEW
• CFR Regulation Number: 878.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-17
• Decision Date: 2013-01-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10848782023674	K123877	000
10848782023667	K123877	000
10848782020888	K123877	000
10848782020758	K123877	000
10848782020727	K123877	000
10848782020703	K123877	000
20705031227979	K123877	000
20705031227962	K123877	000