510(k) K173922

C-PTFETM Surgical Suture by Cp Medical, Inc. — Product Code NBY

K173922 is an FDA 510(k) premarket notification submitted by Cp Medical, Inc. for the device "C-PTFETM Surgical Suture". The FDA issued a decision of Substantially Equivalent on March 26, 2018. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035. Cp Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2018
Date Received
December 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class
Class II
Regulation Number
878.5035
Review Panel
SU
Submission Type