Instrument, Vitreous Aspiration And Cutting, Battery-Powered
The Battery-Powered Vitreous Aspiration and Cutting Instrument is a surgical device used in vitreoretinal surgery to remove vitreous gel from the interior of the eye, allowing access to the retina for therapeutic procedures such as retinal detachment repair. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence before marketing. The product code is HKP, regulated under 21 CFR 886.4150, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.
Basic Information
- Product Code
- HKP
- Device Class
- FDA class 2
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952558 | AARON VAC 2 | Mar 19, 1997 | Substantially Equivalent | AARON MEDICAL INDUSTRIES |
| K950056 | THE GRIESHABER AXIAL CUTTER | May 05, 1995 | Substantially Equivalent | GRIESHABER & CO. |
| K950287 | UNIVIT PROBE | Apr 10, 1995 | Substantially Equivalent | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
| K896622 | VISITEC VITRECTOMY UNIT | Apr 04, 1990 | Substantially Equivalent | VISITEC CO. |
| K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR | Apr 17, 1989 | Substantially Equivalent | MENTOR O & O, INC. |
| K832074 | CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA | Aug 01, 1983 | Substantially Equivalent | COOPERVISION, INC. |
| K822599 | KEATES I/A SYSTEM FRIGITRONICS 4000 | Oct 06, 1982 | Substantially Equivalent | FRIGITRONICS OF CONNECTICUT, INC. |
| K813273 | EMERGENCY POWER PAC (EMPAC) | Dec 31, 1981 | Substantially Equivalent | OPTICAL MICRO SYSTEMS, INC. |
| K810152 | X-VEE | Mar 17, 1981 | Substantially Equivalent | TEMPORATY SURGICAL SYSTEMS |
| K801231 | EYE-VAC | Jul 21, 1980 | Substantially Equivalent | COBURN OPTICAL IND., INC. |
| K791898 | OCUTOME MODEL 8000 | Oct 30, 1979 | Substantially Equivalent | COOPER MEDICAL DEVICES CORP. |
| K791000 | VITREOUS SUCTION/CUTTER | Sep 04, 1979 | Substantially Equivalent | CONCEPT, INC. |
| K790893 | STAT | Aug 28, 1979 | Substantially Equivalent | VARIAN ASSOC., INC. |
| K780852 | CLINITEX VIS-X ASPIRATING ACCESSORY | Nov 03, 1978 | Substantially Equivalent | VARIAN ASSOC., INC. |
| K761353 | VITEROUS SUCTION CUTTER | Jan 05, 1977 | Substantially Equivalent | CONCEPT, INC. |
| K760684 | VISC X-VITREOUS ASPIRATING & CUT. INSTR | Oct 05, 1976 | Substantially Equivalent | VARIAN ASSOC., INC. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.