STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
Device Facts
| Record ID | K960024 |
|---|---|
| Device Name | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH |
| Applicant | Storz Instrument Co. |
| Product Code | HQC · Ophthalmic |
| Decision Date | Sep 20, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4670 |
| Device Class | Class 2 |
Intended Use
The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114), and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
Device Story
Maintenance kit (D7120) and needle wrench (D7125) serve as accessories for phacoemulsification microsurgical systems. Kit includes syringe, stopcock fluidics connectors, needle wrench, and aspirator brush. Used by clinical staff to clean and maintain ultrasonic handpieces; facilitates assembly and disassembly of handpiece components. Non-sterile tools; intended for post-operative maintenance to ensure device functionality. Benefits patient by ensuring proper instrument hygiene and mechanical integrity during cataract extraction procedures.
Clinical Evidence
Bench testing only.
Technological Characteristics
Manual surgical tools including syringe, stopcock, fluidics connectors, needle wrench, and aspirator brush. Non-sterile. Designed for mechanical cleaning and assembly of phacoemulsification handpieces.
Indications for Use
Indicated for cleaning and maintenance of phacoemulsification handpieces used in cataract surgery.
Regulatory Classification
Identification
A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
Predicate Devices
- Alcon Series 20000 LEGACY (K952213)
- AMO Prestige Advanced Cataract Extraction System (K number unknown)
Reference Devices
- Storz DAISY (K854508)
- Storz Protegé (K921758)
- Storz Protegé (K950114)
- Storz PREMIERE (K894278)
- Storz PREMIERE (K921460)
- Storz PREMIERE (K946227)
- Phacoemulsification Handpiece (K935926)
Related Devices
- K955901 — STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX · Storz Instrument Co. · Mar 28, 1996
- K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK · Storz Instrument Co. · Jun 1, 1998
- K980849 — SURGIN KIT · Surgin Surgical Instrumentation, Inc. · Jul 9, 1998
- K050648 — SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK · Advanced Medical Optics, Inc. · Apr 5, 2005
- K961831 — STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK · Storz Instrument Co. · Aug 6, 1996
