MSR · Tubing, Replacement, Phacofragmentation Unit
Ophthalmic · 21 CFR 886.4150 · Class 2
Overview
| Product Code | MSR |
|---|---|
| Device Name | Tubing, Replacement, Phacofragmentation Unit |
| Regulation | 21 CFR 886.4150 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.
Classification Rationale
Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K993361 | TUBING EXTENSION SET | Hurricane Medical | Jan 4, 2000 | SESE |
| K983448 | ML UNIVERSAL TUBING | Med-Logics, Inc. | Dec 18, 1998 | SESE |
| K980849 | SURGIN KIT | Surgin Surgical Instrumentation, Inc. | Jul 9, 1998 | SESE |
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | Storz Instrument Co. | Jun 1, 1998 | SESE |
| K972522 | ML-DISPOSABLE PAK | Med-Logics, Inc. | Sep 30, 1997 | SESE |
Top Applicants
- Med-Logics, Inc. — 2 clearances
- Surgin Surgical Instrumentation, Inc. — 1 clearance
- Storz Instrument Co. — 1 clearance
- Hurricane Medical — 1 clearance
