StitchKit

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Origami Surgical

The following data is part of a premarket notification filed by Origami Surgical with the FDA for Stitchkit.

Pre-market Notification Details

• Device ID: K191317
• 510k Number: K191317
• Device Name: StitchKit
• Classification: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
• Applicant: Origami Surgical 42 Main St. Suite A Madison, NJ 07940
• Contact: John Gillespie
• Correspondent: John Gillespie; Origami Surgical 42 Main St. Suite A Madison, NJ 07940
• Product Code: NBY
• Subsequent Product Code: GCJ
• Subsequent Product Code: NAY
• CFR Regulation Number: 878.5035 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-15
• Decision Date: 2019-07-12