SUTURE LOCK

Retention Device, Suture

SMITH & NEPHEW ENDOSCOPY, INC.

The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Suture Lock.

Pre-market Notification Details

• Device ID: K964935
• 510k Number: K964935
• Device Name: SUTURE LOCK
• Classification: Retention Device, Suture
• Applicant: SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048
• Contact: Susan A Finneran
• Correspondent: Susan A Finneran; SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048
• Product Code: KGS
• CFR Regulation Number: 878.4930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-10
• Decision Date: 1997-02-25
• Summary: summary