Peters Surgical

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2676-2014Class IIThe synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(eJune 25, 2014
Z-2675-2014Class IIThe synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene tJune 25, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K233265Monotime and Optime ROctober 11, 2024
K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)July 12, 2024
K071281UNIRING - ANNULOPLASTY RING WITH SIZERSAugust 3, 2007
K060465PREMIOJanuary 17, 2007
K060163CARDIOFLON, CARDIOXYLOctober 11, 2006
K062366OPTIME, SINUSORB PGAOctober 2, 2006
K052701COROLENEDecember 13, 2005