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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 K123811
Device Name STITCHKIT
Applicant
Origami Surgical, LLC
79 Haven St.
Dover,  MA  02030
Applicant Contact JOHN GILLESPIE
Correspondent
Origami Surgical, LLC
79 Haven St.
Dover,  MA  02030
Correspondent Contact JOHN GILLESPIE
Regulation Number878.5035
Classification Product Code
NBY  
Subsequent Product Codes
GCJ   NAY  
Date Received12/11/2012
Decision Date 09/05/2013
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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