StitchKit

Suture, Nonabsorbable, Synthetic, Polypropylene

ORIGAMI SURGICAL LLC

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

Pre-market Notification Details

• Device ID: K142639
• 510k Number: K142639
• Device Name: StitchKit
• Classification: Suture, Nonabsorbable, Synthetic, Polypropylene
• Applicant: ORIGAMI SURGICAL LLC 42 Main St. Suite A Madison, NJ 07940
• Contact: Patrick Culligan
• Correspondent: John Gillespie; Clover Medical LLC 79 Haven St. Dover, MA 02030
• Product Code: GAW
• Subsequent Product Code: GCJ
• Subsequent Product Code: NAY
• CFR Regulation Number: 878.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2014-09-17
• Decision Date: 2014-12-16
• Summary: summary