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PETERS SURGICAL

US

Last updated May 27, 2026

What PETERS SURGICAL makes

Peters Surgical manufactures a range of surgical sutures, including polyester (both bioabsorbable and non-bioabsorbable), nylon, and metallic monofilament and multifilament variants, as well as bioabsorbable polyester sutures without antimicrobial properties. Their portfolio also includes metallic ligation clips and devices for applying these clips during open surgery.

The company’s products are regulated under the FDA’s UDI system, with devices classified as Class I and Class II. These sutures and clips are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Peters Surgical manufacture?

Peters Surgical specializes in surgical sutures and ligation devices. Their product range includes polyester sutures (both bioabsorbable and non-bioabsorbable, in monofilament and multifilament forms), nylon sutures (non-bioabsorbable, monofilament), and metallic sutures (monofilament). They also produce metallic ligation clips and open-surgery clip appliers. These devices are designed for use in various surgical procedures.

Where is Peters Surgical based, and what regulatory framework applies to their devices?

Peters Surgical is based in the United States. Their devices are regulated under the FDA’s Unique Device Identifier (UDI) system, which ensures traceability and compliance with U.S. medical device regulations. The company’s products are classified under FDA categories, including Class I and Class II, depending on their intended use and risk level.

Are Peters Surgical’s devices listed in any regulatory registries, and why does this matter?

Yes, Peters Surgical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to track and identify medical devices throughout their lifecycle, ensuring transparency, safety, and compliance with U.S. regulatory requirements. Listing in the UDI system helps healthcare providers, regulators, and manufacturers maintain accurate records.

How are Peters Surgical’s devices classified by regulatory authorities, and what does this classification mean?

Peters Surgical’s devices are classified as either Class I or Class II under FDA regulations. Classification determines the level of regulatory control and scrutiny a device undergoes. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve higher risks and require special controls to ensure safety and effectiveness. The classification ensures appropriate oversight based on the device’s potential impact on patient safety.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
+1 508-747-6033
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
265741780

Catalogue (1040)

Page 21 of 21
DeviceModel / ReferenceRegistriesClassStatus
Corolene® 20S15Q
FDA UDI
Class IIActive
Corolene® 20S15J
FDA UDI
Class IIActive
Acier 31720821
FDA UDI
Class IIActive
Applier, hemostatic clip PW615-E
FDA UDI
Class IActive
Cardioxyl ® 73P30BC
FDA UDI
Class IIActive
Corolene® 20S15BC
FDA UDI
Class IIActive
Corolene® 20I15KZ
FDA UDI
Class IIActive
Optime R 12S35F
FDA UDI
Class IIActive
Optime R 12S20C
FDA UDI
Class IIActive
Corolene® 20S20J
FDA UDI
Class IIActive
Sinusorb® Pga 8140
FDA UDI
Class IIActive
Cardioxyl ® 73P30CF
FDA UDI
Class IIActive
Corolene® 20S15AH
FDA UDI
Class IIActive
Sls-Clip Vitalitec R1120-1
FDA UDI
Class IIActive
Optime R 12S35A
FDA UDI
Class IIActive
Cardioxyl ® 73P30I
FDA UDI
Class IIActive
Applier, hemostatic clip PR115-E
FDA UDI
Class IActive
Acier 31720830
FDA UDI
Class IIActive
Clip 9 Vitalitec L9180
FDA UDI
Class IIActive
Acier 31720825
FDA UDI
Class IIActive
Applier, hemostatic clip PJ120-E
FDA UDI
Class IActive
Applier, hemostatic clip POC428-E
FDA UDI
Class IActive
Clip 9 Vitalitec B9324
FDA UDI
Class IIActive
Applier, hemostatic clip PO420-E
FDA UDI
Class IActive
Acier 31762
FDA UDI
Class IIActive
Applier, hemostatic clip PRT128-1B
FDA UDI
Class IUnknown
Applier, hemostatic clip PV328-EB
FDA UDI
Class IActive
Sls-Clip Vitalitec O4120-1
FDA UDI
Class IIActive
Applier, hemostatic clip PJT120-1B
FDA UDI
Class IUnknown
Applier, hemostatic clip PJ115-EB
FDA UDI
Class IActive
Applier, hemostatic clip PJ115-E
FDA UDI
Class IActive
Applier, hemostatic clip PO420-EB
FDA UDI
Class IActive
Acier 31766
FDA UDI
Class IIActive
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) K232372
FDA 510(k)
Class IIActive
Monotime and Optime R K233265
FDA 510(k)
Class IIActive
Cardioflon, Cardioxyl K060163
FDA 510(k)
Class IIActive
Premio K060465
FDA 510(k)
Class IIActive
Corolene K052701
FDA 510(k)
Class IIActive
Optime, Sinusorb Pga K062366
FDA 510(k)
Class IIActive
Uniring - Annuloplasty Ring With Sizers K071281
FDA 510(k)
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Peters Surgical DOMALAIN Bretagne · FR FEI 3001650400