Visc X-Vitreous Aspirating & Cut. Instr
FDA 510(k) K760684 · Varian Assoc., Inc.
510(k) numberK760684
Submission
- Device name
- Visc X-Vitreous Aspirating & Cut. Instr
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- September 20, 1976
- Decision date
- October 5, 1976
- 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
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| 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 |
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Questions and answers
When was Visc X-Vitreous Aspirating & Cut. Instr cleared by the FDA?
Visc X-Vitreous Aspirating & Cut. Instr (K760684) received a 510(k) decision of Substantially Equivalent on October 5, 1976, 15 days after the submission was received.
What is the product code of K760684?
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.