Ocutome Model 8000
FDA 510(k) K791898 · Cooper Medical Devices Corp.
510(k) numberK791898
Submission
- Device name
- Ocutome Model 8000
- Applicant
- Cooper Medical Devices Corp.
Mchenry, IL, US - Received
- September 25, 1979
- Decision date
- October 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKP – Instrument, Vitreous Aspiration And Cutting, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
Other 510(k)s with product code HKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952558 | Aaron Vac 2HKP · Traditional | Aaron Medical Industries | 03/19/1997SE |
| K950056 | The Grieshaber Axial CutterHKP · Traditional | Grieshaber & Co. | 05/05/1995SE |
| K950287 | Univit ProbeHKP · Traditional | Medical Instrument Development Laboratories, Inc. | 04/10/1995SE |
| K896622 | Visitec Vitrectomy UnitHKP · Traditional | Visitec Co. | 04/04/1990SE |
| K890595 | Mentor Anterior Segment VitrectorHKP · Traditional | Mentor O & O, Inc. | 04/17/1989SE |
| K832074 | Cavitron/Kelman Phaco-Emulsifier AspiraHKP · Traditional | CooperVision, Inc. | 08/01/1983SE |
| K822599 | Keates I/A System Frigitronics 4000HKP · Traditional | Frigitronics of Connecticut, Inc. | 10/06/1982SE |
| K813273 | Emergency Power Pac (Empac)HKP · Traditional | Optical Micro Systems, Inc. | 12/31/1981SE |
| K810152 | X-VeeHKP · Traditional | Temporaty Surgical Systems | 03/17/1981SE |
| K801231 | Eye-VacHKP · Traditional | Coburn Optical Ind., Inc. | 07/21/1980SE |
More from Coburn Optical Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802971 | Landers Contact LensHJI · Traditional | 02/05/1981SE |
| K802927 | Sebestyen Irrigating Contact LensHJI · Traditional | 02/05/1981SE |
| K801850 | Charles Pneumatic Intraocular ScissorsHQE · Traditional | 09/16/1980SE |
| K801411 | May Illuminated/Infusion PicHMX · Traditional | 07/21/1980SE |
| K801312 | The Protectors · Traditional | 06/17/1980SE |
| K800833 | Vabra AspiratorHHI · Traditional | 05/14/1980SE |
Questions and answers
When was Ocutome Model 8000 cleared by the FDA?
Ocutome Model 8000 (K791898) received a 510(k) decision of Substantially Equivalent on October 30, 1979, 35 days after the submission was received.
What is the product code of K791898?
The FDA product code is HKP – Instrument, Vitreous Aspiration And Cutting, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.