Supramid Extra Sutures

FDA PMAFDA 510(k)

Class II (US FDA PMA)

PMA N80838510(k) K912429

by S. Jackson, Inc.

Identity

Trade Name: SUPRAMID EXTRA SUTURES FDA PMA
Generic Name: Suture, nonabsorbable, synthetic, polyamide FDA PMA

Identifiers

PMA Number: N80838 FDA PMA
510(k) Number: K912429 FDA PMA
FDA Product Code: GAR FDA PMA

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 878.5020 FDA PMA
Regulation Number: 878.5020 FDA PMA
Advisory Committee: General, Plastic Surgery FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA
PMA Supplement: S008 FDA PMA

Supramid Extra Sutures are nonabsorbable, synthetic polyamide sutures designed for surgical use. These devices are indicated for use in general and plastic surgery procedures.

This device is manufactured by S. Jackson, Inc. and is regulated under the product code GAR. Please refer to the product packaging for specific information regarding sterility, intended use, and storage requirements.

Frequently asked questions

What type of material is used in Supramid Extra Sutures?

Supramid Extra Sutures are composed of a synthetic, nonabsorbable polyamide material.

What medical specialties are these sutures intended for?

These sutures are categorized for use within general and plastic surgery applications.

Are these sutures absorbable?

No, Supramid Extra Sutures are classified as nonabsorbable, meaning they do not break down within the body over time.

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: Supramid

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K931613	Class II	Active
FDA 510(k)	United States	FDA_510K	K912429	Class II	Active
FDA 510(k)	United States	FDA_510K	K904052	Class II	Active
FDA PMA	United States	FDA_PMA	N80838	Class II	Active

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Manufacturer

Manufacturer: S. Jackson, Inc.

Sources (2)

FDA PMA N80838 36 fields · synced Sep 18, 2026
FDA 510(k) K931613 1 fields · synced May 18, 2026