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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(k) Number K191317
Device Name StitchKit
Applicant
Origami Surgical
42 Main St. Suite A
Madison,  NJ  07940
Applicant Contact John Gillespie
Correspondent
Origami Surgical
42 Main St. Suite A
Madison,  NJ  07940
Correspondent Contact John Gillespie
Regulation Number878.5035
Classification Product Code
NBY  
Subsequent Product Codes
GCJ   NAY  
Date Received05/15/2019
Decision Date 07/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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