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Storz Micro Cutter 25 Gauge Pack

by Storz

510(k) K913504

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK913504 Date21 Feb 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQE
Device Class
Class II
Regulation
21 CFR Part 886.4150
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Micro Cutter 25 Gauge Pack is an ac-powered vitreous aspiration and cutting instrument designed for ophthalmic procedures. Classified as a Class II medical device, it is intended for precise tissue manipulation during vitreoretinal surgeries, including vitrectomy and capsulotomy.

This single-use device is supplied sterile and intended for use in controlled surgical environments. It is regulated under FDA 510(k) clearance (K913504) and falls under the 886.4150 product code for ophthalmic instruments. The 25-gauge size is optimized for minimally invasive procedures, requiring no additional regulatory markings beyond its designated classification.

Other devices from Storz

Questions

AI-generated answers, 18 Sep 2026

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

  • What types of ophthalmic surgeries is the Storz Micro Cutter 25 Gauge Pack specifically designed for?

    The Storz Micro Cutter 25 Gauge Pack is designed for precise tissue manipulation during vitreoretinal surgeries, including vitrectomy and capsulotomy. Its 25-gauge size is optimized for minimally invasive procedures, making it suitable for delicate surgical environments where fine control is essential.

  • Is the Storz Micro Cutter 25 Gauge Pack intended for single-use or repeated use in a clinical setting?

    The Storz Micro Cutter 25 Gauge Pack is explicitly labeled as a single-use device. This ensures sterility and safety for controlled surgical environments, reducing the risk of cross-contamination between patients.

  • How is the Storz Micro Cutter 25 Gauge Pack supplied, and what should be considered for storage?

    The device is supplied sterile, ready for immediate use in surgical settings. Since it is single-use, storage should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use.

  • What regulatory pathway was followed for FDA clearance of the Storz Micro Cutter 25 Gauge Pack?

    The Storz Micro Cutter 25 Gauge Pack received FDA clearance through a 510(k) submission (K913504) under the Traditional clearance type, determined to be substantially equivalent to a predicate device. It falls under product code 886.4150 for ophthalmic instruments and was reviewed by the Ophthalmic (OP) Advisory Committee.