Storz Microflow Phacoemulsification Needle
by Storz
510(k) K954340
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954340 | Date14 Dec 1995 | StatusActive |
Recalls
-
- Terminated Z-1727-2010
- Terminated Z-1726-2010
- Terminated Z-1730-2010
- Terminated Z-1725-2010
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
-
- Terminated Z-1279-03
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 1 Oct 2026
The Storz Microflow Phacoemulsification Needle is a phacofragmentation device designed for ultrasonic surgical removal of the cataractous crystalline lens during cataract surgery. It operates as part of an AC-powered phacoemulsification system, using ultrasound energy to fragment and emulsify lens material for extraction.
This needle is supplied as a single-use accessory for use with a phacoemulsification handpiece in ophthalmic settings. It is classified as a Class II medical device under FDA regulations (886.4670) and holds a 510(k) clearance (K954340) for substantial equivalence. Multiple needle variants are registered, each identified by unique FEI numbers, and are intended for sterile, one-time-per-patient use in controlled surgical environments.
Other devices from Storz
Questions
AI-generated answers, 1 Oct 2026
What is the Storz Microflow Phacoemulsification Needle used for?
This needle is designed specifically for phacofragmentation during cataract surgery. It uses ultrasound energy—part of an AC-powered phacoemulsification system—to break down and emulsify the clouded lens material so it can be safely removed from the eye. It’s intended for use in controlled surgical environments where precision and efficiency are critical.
How is the Storz Microflow Phacoemulsification Needle supplied, and is it reusable?
The needle is supplied as a single-use accessory, meaning it is intended for one-time use per patient. This ensures sterility and reduces the risk of cross-contamination in surgical settings. Reuse is not recommended or approved for this device.
What distinguishes the different variants of this needle, and how do I identify them?
Each variant of the Storz Microflow Phacoemulsification Needle is identified by a unique FEI (Firmware Element Identifier) number. These numbers appear in the device’s registration records and help clinicians or purchasing departments select the correct model for their specific phacoemulsification system. Examples include FEI numbers like 1000120314, 3006695864, and others listed in the regulatory database.
How should the Storz Microflow Phacoemulsification Needle be stored?
Since this is a sterile, single-use device, it should be stored in its original, unopened packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Follow the manufacturer’s instructions for shelf-life and storage conditions to maintain sterility and functionality.
Is this device approved for use in the U.S., and what regulatory pathway was followed?
Yes, the Storz Microflow Phacoemulsification Needle holds FDA 510(k) clearance (K954340) under the substantial equivalence pathway. This means it was determined to be as safe and effective as a legally marketed predicate device. The device is classified as Class II under FDA regulations (886.4670) and is intended for use in ophthalmic settings as part of a phacoemulsification system.