STITCHKIT

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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: K123811
• 510k Number: K123811
• Device Name: STITCHKIT
• Classification: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
• Applicant: ORIGAMI SURGICAL LLC 79 HAVEN ST. Dover, MA 02030
• Contact: John Gillespie
• Correspondent: John Gillespie; ORIGAMI SURGICAL LLC 79 HAVEN ST. Dover, MA 02030
• 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: 2012-12-11
• Decision Date: 2013-09-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860088000206	K123811	000
00860088000237	K123811	000