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Phaco Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K942515

by Surgin Surgical Instrumentation, Inc.

Identifiers

510(k) Number
K942515 FDA 510(k)
FDA Product Code
HQC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4670 FDA 510(k)
Regulation Number
886.4670 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a unit for phacofragmentation, classified as an ophthalmic surgical accessory kit. It is designed for use with the Alcon Series 20,000 Legacy Phacoemulsifier and provides necessary components for automated irrigation and aspiration during phacoemulsification procedures.

The device was cleared via the FDA 510(k) pathway under K942515, with a traditional clearance decision and product code HQC. It is manufactured by Surgin Surgical Instrumentation, Inc. and is intended for use in ophthalmic settings as part of phacoemulsification surgery.

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: SURGIN KIT (K980849) — FDA 510(k) | Innolitics, Surgin Surgical Instrumentation Inc. - AeroBase Group, The Future of Phaco | Surgical Design, Surgin Surgical Instrumentation Inc. - AeroBase Group

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Surgin Surgical Instrumentation, Inc.

Sources (1)

  • FDA 510(k) K942515 24 fields · synced Sep 22, 2026