QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE

Suture, Absorbable, Synthetic, Polyglycolic Acid

SURGICAL SPECIALTIES CORP.

The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Quill Monoderm Knotless Tissue-closure Device.

Pre-market Notification Details

• Device ID: K141558
• 510k Number: K141558
• Device Name: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606
• Contact: Kirsten Stowell Franco
• Correspondent: Kirsten Stowell Franco; SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-12
• Decision Date: 2014-07-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10848782022073	K141558	000
10848782022066	K141558	000
10848782022059	K141558	000
10848782022042	K141558	000