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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K142639
Device Name StitchKit
Applicant
Origami Surgical, LLC
42 Main St. Suite A
Madison,  NJ  07940
Applicant Contact Patrick Culligan
Correspondent
Clover Medical, LLC
79 Haven St.
Dover,  MA  02030
Correspondent Contact John Gillespie
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Codes
GCJ   NAY  
Date Received09/17/2014
Decision Date 12/16/2014
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 Yes
Predetermined Change
Control Plan Authorized		 No
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