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Molteno Valve Seton

FDA 510(k)

Class II (US FDA 510(k))

510(k) K875099

by Staar Surgical Co.

Identifiers

510(k) Number
K875099 FDA 510(k)
FDA Product Code
KYF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.3920 FDA 510(k)
Regulation Number
886.3920 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Molteno Valve Seton is an implantable eye valve device classified under product code KYF as an Implant, Eye Valve. It is designed for ophthalmic use and has been determined to be substantially equivalent to a predicate device through the FDA 510(k) clearance process.

The device is supplied as a sterile implant for single-use implantation in ophthalmic surgical settings. It is regulated as a Class II medical device under FDA regulation number 886.3920, with special controls applied, and was cleared via traditional 510(k) pathway under K875099 on March 30, 1988.

Frequently asked questions

What is the Molteno Valve Seton used for?

The Molteno Valve Seton is an implantable eye valve designed for ophthalmic use, intended to regulate intraocular pressure in surgical settings as a sterile, single-use implant.

How is the Molteno Valve Seton supplied and is it reusable?

The device is supplied as a sterile implant for single-use implantation only; it is not intended for reuse, reprocessing, or resterilization after initial use in ophthalmic surgery.

What regulatory pathway and classification apply to the Molteno Valve Seton?

The Molteno Valve Seton is a Class II medical device regulated under FDA regulation number 886.3920, cleared via the traditional 510(k) pathway under K875099 on March 30, 1988, as substantially equivalent to a predicate device.

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: K875099 FDA 510(k) - MOLTENO VALVE SETON | Staar Surgical Co., MOLTENO VALVE SETON (K875099) — FDA 510(k) | Innolitics, Molteno Valve Seton - Beudamed, PDF K875099 MOLTENO VALVE SETON - 510kdatabase.net, MOLTENO VALVE SETON 510 (k) K875099 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Staar Surgical Co.

Sources (1)

  • FDA 510(k) K875099 24 fields · synced Sep 22, 2026