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Storz D7116 Microvit Vitrectomy Cutter Extension

by Storz Instrument Co. 510(k)

Active United States

510(k) K960003

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960003 Date29 Aug 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Storz D7116 Microvit Vitrectomy Cutter Extension is an accessory device used in ophthalmic surgery to provide a snap-on grip extension for the Storz Microvit Vitrectomy Cutter, facilitating instrument manipulation. It attaches to the existing cutter without altering its function.

The device is supplied for use in clinical or operating room settings to improve ergonomics and handling of vitrectomy probes. It is a single-use or reusable device, and its storage and use are subject to the manufacturer's instructions. The device has been cleared under FDA 510K, with the regulation number 886.4670 and product code HQC.

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