Peters Surgical

• GAM — General, Plastic Surgery3 devices
• GAT — General, Plastic Surgery1 device
• GAW — General, Plastic Surgery1 device
• KRH — Cardiovascular1 device
• MXW — General, Plastic Surgery1 device

• Z-2676-2014 — The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).Class II·Terminated·2014-06-25
• Z-2675-2014 — The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).Class II·Terminated·2014-06-25

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K233265 — Monotime and Optime RCode GAM·2024-10-11
• K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Code GAM·2024-07-12
• K071281 — UNIRING - ANNULOPLASTY RING WITH SIZERSCode KRH·2007-08-03
• K060465 — PREMIOCode MXW·2007-01-17
• K060163 — CARDIOFLON, CARDIOXYLCode GAT·2006-10-11
• K062366 — OPTIME, SINUSORB PGACode GAM·2006-10-02
• K052701 — COROLENECode GAW·2005-12-13