HKP · Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Ophthalmic · 21 CFR 886.4150 · Class 2
Overview
| Product Code | HKP |
|---|---|
| Device Name | Instrument, Vitreous Aspiration And Cutting, Battery-Powered |
| Regulation | 21 CFR 886.4150 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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 (16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952558 | AARON VAC 2 | Aaron Medical Industries | Mar 19, 1997 | SESE |
| K950056 | THE GRIESHABER AXIAL CUTTER | Grieshaber & Co. | May 5, 1995 | SESE |
| K950287 | UNIVIT PROBE | Medical Instrument Development Laboratories, Inc. | Apr 10, 1995 | SESE |
| K896622 | VISITEC VITRECTOMY UNIT | Visitec Co. | Apr 4, 1990 | SESE |
| K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR | Mentor O & O, Inc. | Apr 17, 1989 | SESE |
| K832074 | CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA | CooperVision, Inc. | Aug 1, 1983 | SESE |
| K822599 | KEATES I/A SYSTEM FRIGITRONICS 4000 | Frigitronics of Connecticut, Inc. | Oct 6, 1982 | SESE |
| K813273 | EMERGENCY POWER PAC (EMPAC) | Optical Micro Systems, Inc. | Dec 31, 1981 | SESE |
| K810152 | X-VEE | Temporaty Surgical Systems | Mar 17, 1981 | SESE |
| K801231 | EYE-VAC | Coburn Optical Ind., Inc. | Jul 21, 1980 | SESE |
| K791898 | OCUTOME MODEL 8000 | Cooper Medical Devices Corp. | Oct 30, 1979 | SESE |
| K791000 | VITREOUS SUCTION/CUTTER | Concept, Inc. | Sep 4, 1979 | SESE |
| K790893 | STAT | Varian Assoc., Inc. | Aug 28, 1979 | SESE |
| K780852 | CLINITEX VIS-X ASPIRATING ACCESSORY | Varian Assoc., Inc. | Nov 3, 1978 | SESE |
| K761353 | VITEROUS SUCTION CUTTER | Concept, Inc. | Jan 5, 1977 | SESE |
| K760684 | VISC X-VITREOUS ASPIRATING & CUT. INSTR | Varian Assoc., Inc. | Oct 5, 1976 | SESE |
Top Applicants
- Varian Assoc., Inc. — 3 clearances
- Concept, Inc. — 2 clearances
- Visitec Co. — 1 clearance
- Temporaty Surgical Systems — 1 clearance
- Optical Micro Systems, Inc. — 1 clearance
