510(k) K950056
- Device
- THE GRIESHABER AXIAL CUTTER
- Applicant
- GRIESHABER & CO.
- 510(k) number
- K950056
- Product code
- HKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-05
- Date received
- 1995-01-06
- Regulation
- 886.4150
- Classification name
- Instrument, Vitreous Aspiration And Cutting, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANK J TIGHE
- Address
- 1945 Vaughn Rd. P.O. Box 440609 Kennesaw GA US 30144 30144
FDA Registration Numbers#
- 2028523
- 3012236936
- 3002907620
- 2953359
- 2935428
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HKP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952558 | AARON VAC 2 | Aaron Medical Industries | 1997-03-19 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases