510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Peters Surgical

DOMALAIN Bretagne, FR

PETERS SURGICAL appears in FDA device records in DOMALAIN Bretagne, FR. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
2
Registered establishments
2

510(k) clearance history

FDA records hold 7 510(k) clearances for Peters Surgical between 2005 and 2024. The busiest year on record is 2006, with 2. The most recent is 2024, with 2.

Clearances by year, as a table
510(k) clearance decisions for Peters Surgical, by decision year
YearClearances
20051
20062
20072
20242
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K233265Monotime and Optime RGAMSubstantially Equivalent
K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)GAMSubstantially Equivalent
K071281UNIRING - ANNULOPLASTY RING WITH SIZERSKRHSubstantially Equivalent
K060465PREMIOMXWSubstantially Equivalent
K060163CARDIOFLON, CARDIOXYLGATSubstantially Equivalent
K062366OPTIME, SINUSORB PGAGAMSubstantially Equivalent
K052701COROLENEGAWSubstantially Equivalent

Registered establishments

FDA registered establishments for Peters Surgical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30016504003001650400PETERS SURGICALZ.A. VAGUE DE LA NOE, DOMALAIN Bretagne 35680 FR2026
30040601073004060107PETERS SURGICALImmeuble Aurelium, BOULOGNE-BILLANCOURT Hauts-de-Seine 92100 FR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2676-2014The 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).A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.Class IITerminated
Z-2675-2014The 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).A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain