Foil in 3 Forms-Non-Sterile Sheets

FDA 510(k)

Class II (US FDA 510(k))

510(k) K831725

Identifiers

510(k) Number: K831725 FDA 510(k)
FDA Product Code: FTM FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.3300 FDA 510(k)
Regulation Number: 878.3300 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a surgical mesh, as defined by its device name and classification. It is provided in three forms as non-sterile sheets.

The device is supplied non-sterile and is intended for use in general and plastic surgery settings. It has received FDA 510(k) clearance under K831725 and is classified as a Class II device under regulation number 878.3300.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K831725	Class II	Active

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Manufacturer

Manufacturer: S. Jackson, Inc.

Sources (1)

FDA 510(k) K831725 24 fields · synced Sep 23, 2026