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Vital Sutures Suturex Cirugia Peruana

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100780

by Unilene Sac

Identifiers

510(k) Number
K100780 FDA 510(k)
FDA Product Code
NEW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4840 FDA 510(k)
Regulation Number
878.4840 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an absorbable, synthetic surgical suture composed of polydioxanone, classified under the nomenclature for absorbable sutures. It is designed to approximate and ligate soft tissues during surgical procedures, providing temporary mechanical support as it gradually degrades and is absorbed by the body.

The sutures are supplied in sterile, single-use packaging and are intended for use in general and plastic surgery settings. They are non-magnetic and compatible with MRI environments. Available in various sizes and configurations, they require sterile storage and are regulated under FDA 510(k) clearance (K100780) as substantially equivalent to predicate devices. No additional regulatory markings beyond those specified are indicated.

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: K123034 FDA 510(k) - VITAL SUTURES SUTUREX CIRUGIA PERUANA S..., VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (K123034) — FDA 510 (k ..., VITAL SUTURES, SUTUREX, CIRUGIA PERUANA (K100780) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Unilene Sac

Sources (1)

  • FDA 510(k) K100780 24 fields · synced Oct 6, 2026