Product code HKP
- Device name
- Instrument, Vitreous Aspiration And Cutting, Battery-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4150
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952558 | AARON VAC 2 | Aaron Medical Industries | 1997-03-19 |
| K950056 | THE GRIESHABER AXIAL CUTTER | Grieshaber & Co. | 1995-05-05 |
| K950287 | UNIVIT PROBE | Medical Instrument Development Laboratories, Inc. | 1995-04-10 |
| K896622 | VISITEC VITRECTOMY UNIT | Visitec Co. | 1990-04-04 |
| K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR | Mentor O & O, Inc. | 1989-04-17 |
| K832074 | CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA | CooperVision, Inc. | 1983-08-01 |
| K822599 | KEATES I/A SYSTEM FRIGITRONICS 4000 | Frigitronics of Connecticut, Inc. | 1982-10-06 |
| K813273 | EMERGENCY POWER PAC (EMPAC) | Optical Micro Systems, Inc. | 1981-12-31 |
| K810152 | X-VEE | Temporaty Surgical Systems | 1981-03-17 |
| K801231 | EYE-VAC | Coburn Optical Ind., Inc. | 1980-07-21 |
| K791898 | OCUTOME MODEL 8000 | Cooper Medical Devices Corp. | 1979-10-30 |
| K791000 | VITREOUS SUCTION/CUTTER | Concept, Inc. | 1979-09-04 |
| K790893 | STAT | Varian Assoc., Inc. | 1979-08-28 |
| K780852 | CLINITEX VIS-X ASPIRATING ACCESSORY | Varian Assoc., Inc. | 1978-11-03 |
| K761353 | VITEROUS SUCTION CUTTER | Concept, Inc. | 1977-01-05 |
| K760684 | VISC X-VITREOUS ASPIRATING & CUT. INSTR | Varian Assoc., Inc. | 1976-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10818255010487 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010609 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010708 | NA | MICROVISION, INC. | 2018-01-17 |
| 10818255010432 | NA | MICROVISION, INC. | 2018-01-17 |
| 00812480010314 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | 2017-06-24 |
| 00812480010307 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | 2017-06-24 |
| 00812480010963 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | 2016-09-23 |
| 00812480010956 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | 2016-09-23 |
| 00812480010949 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | 2016-09-23 |
| 00812480010277 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | 2016-09-23 |
| 00812480010222 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | 2016-09-23 |
| 00812480010215 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | 2016-09-23 |
| 00856222004667 | RETRECTOR® | INSIGHT INSTRUMENTS, INC. | 2016-09-23 |
| 00856222004643 | INTRECTOR® | INSIGHT INSTRUMENTS, INC. | 2016-09-23 |
| 00856222004193 | INTRECTOR® | INSIGHT INSTRUMENTS, INC. | 2016-09-23 |
| 00856222004186 | INTRECTOR® | INSIGHT INSTRUMENTS, INC. | 2016-09-23 |
| 00852475007011 | Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga | INSIGHT INSTRUMENTS, INC. | 2016-09-23 |
| 00852475007004 | Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga | INSIGHT INSTRUMENTS, INC. | 2016-09-23 |
| 05050474520509 | AMO TAC INFUSION SLEEVE | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2016-09-02 |
| 05050474520493 | AMO LIMBAL NEEDLE ASSEMBLY | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2016-09-02 |
| 05050474520479 | AMO TAC VITRECTOMY HANDPIECE | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2016-09-02 |