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Polyester Nonabsorbable Surgical Sutures URP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001172

by Cp Medical

Identifiers

510(k) Number
K001172 FDA 510(k)
FDA Product Code
GAT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5000 FDA 510(k)
Regulation Number
878.5000 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SN FDA 510(k)

Polyester nonabsorbable surgical sutures URP are multifilament, sterile, flexible threads made from high molecular weight, long-chain, linear polyesters with recurrent aromatic rings. They are intended for use in soft tissue approximation.

These sutures are supplied sterile and are designed for single-use applications. They are not indicated for use in areas subject to continuous muscle tension or in cardiovascular tissue. The device is regulated under FDA 510(k) clearance.

Frequently asked questions

What are Polyester Nonabsorbable Surgical Sutures URP used for?

These sutures are intended for use in soft tissue approximation, as they are multifilament, sterile, flexible threads made from high molecular weight polyesters designed to approximate soft tissues during surgical procedures.

How are Polyester Nonabsorbable Surgical Sutures URP supplied and are they reusable?

The sutures are supplied sterile and are designed for single-use applications only, meaning they should not be resterilized or reused after initial use to maintain sterility and performance integrity.

Are there any tissue types where Polyester Nonabsorbable Surgical Sutures URP should not be used?

These sutures are not indicated for use in areas subject to continuous muscle tension or in cardiovascular tissue, as specified in the device description, to avoid potential failure or complications in high-stress or dynamic anatomical locations.

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: POLYESTER NONABSORBABLE SURGICAL SUTURES URP (K001172) — FDA 510 (k ..., POLYESTER NONABSORBABLE SURGICAL SUTURES URP by CP MEDICAL | FDA 510 (k ..., PDF K001172 - Polyester Nonabsorbable Surgical Sutures Urp, CP Medical leading manufacturer of surgical solutions |

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cp Medical

Sources (1)

  • FDA 510(k) K001172 24 fields · synced Sep 28, 2026