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CP Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
32
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0655-2020Class IICoated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)107909October 18, 2019
Z-1027-2019Class IIPlain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: PFebruary 4, 2019
Z-1872-2017Class IIPGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, SteFebruary 2, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K173922C-PTFETM Surgical SutureMarch 26, 2018
K094028CP-FIBER (ORTHOFIBER)March 18, 2010
K072229MONOSWIFTOctober 5, 2007
K071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSJuly 18, 2007
K060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31November 2, 2006
K041894ORTHOFIBERSeptember 17, 2004
K034062CP SLEEVE AND RIVER SLEEVEJanuary 30, 2004
K024372CP MEDICAL BONE WAXJune 19, 2003
K030786MONO-SWIFTMay 6, 2003
K030351STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLEMarch 28, 2003
K023710VISORB SWIFTJanuary 17, 2003
K022075DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5September 19, 2002
K021311SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIALJuly 13, 2002
K013975CP-SLEEVEFebruary 22, 2002
K013964MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERSJanuary 24, 2002
K013274MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILENovember 16, 2001
K010621ACCU-SPACE ABSORBABLE SEEDING SPACERSSeptember 4, 2001
K002190POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)August 10, 2000
K001172POLYESTER NONABSORBABLE SURGICAL SUTURES URPJune 23, 2000
K001173NYLON, NONABSORBABLE SURGICAL SUTURES USPJune 23, 2000