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Peters Surgical ADVANTIME Absorbable Suture

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232372

by Peters Surgical

Identifiers

510(k) Number
K232372 FDA 510(k)
FDA Product Code
GAM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4493 FDA 510(k)
Regulation Number
878.4493 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Peters Surgical ADVANTIME Absorbable Suture is a synthetic, monofilament suture classified as an absorbable suture under the nomenclature authority. It is composed of poly(glycolide-co-caprolactone) (PGCL) and designed for soft tissue approximation and ligation in general surgical procedures. This device is intended for use in open or laparoscopic surgery, excluding cardiovascular, microsurgery, ophthalmic, and neurological applications.

The suture is supplied in a sterile, single-use format and is intended for one-time clinical application. It adheres to FDA 510(k) clearance (K232372) under the classification of Class II medical devices (regulation number 878.4493). No specific MRI safety information is provided, and sizes are referenced by the listed FEI numbers. Storage conditions and additional regulatory details are not specified in the provided data.

Frequently asked questions

What types of surgical procedures is the Peters Surgical ADVANTIME Absorbable Suture intended for, and where can it be used in the body?

The Peters Surgical ADVANTIME Absorbable Suture is designed for soft tissue approximation and ligation in general surgical procedures. It is suitable for both open and laparoscopic surgeries, but it is explicitly excluded for use in cardiovascular, microsurgery, ophthalmic, and neurological applications.

Is the Peters Surgical ADVANTIME Absorbable Suture meant for single-use or can it be reused?

The Peters Surgical ADVANTIME Absorbable Suture is supplied in a sterile, single-use format and is intended for one-time clinical application only. This ensures patient safety and sterility.

How do I identify the different sizes or models of the Peters Surgical ADVANTIME Absorbable Suture?

The suture sizes are referenced by FEI numbers, which are unique identifiers listed in the specifications. These FEI numbers (e.g., 3003495548, 3038718579) help distinguish between different models and sizes available for clinical use.

What regulatory pathway was followed for the FDA clearance of the Peters Surgical ADVANTIME Absorbable Suture?

The Peters Surgical ADVANTIME Absorbable Suture received FDA clearance through a 510(k) submission, specifically under the classification of Class II medical devices (regulation number 878.4493). The clearance type is abbreviated, and it was reviewed by the Surgical Devices Panel (SU) under the General, Plastic Surgery advisory committee.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (K232372) — FDA ..., K232372 - Peters Surgical ADVANTIME Absorbable Suture (A..., Sutures - Advanced Medical Solutions - Peters Surgical Worldwide, Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (K232372) — FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Peters Surgical

Sources (1)

  • FDA 510(k) K232372 24 fields · synced Sep 19, 2026