X-Vee
FDA 510(k) K810152 · Temporaty Surgical Systems
510(k) numberK810152
Submission
- Device name
- X-Vee
- Applicant
- Temporaty Surgical Systems
Walker, MI, US - Received
- January 21, 1981
- Decision date
- March 17, 1981
- 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 |
| K801231 | Eye-VacHKP · Traditional | Coburn Optical Ind., Inc. | 07/21/1980SE |
| K791898 | Ocutome Model 8000HKP · Traditional | Cooper Medical Devices Corp. | 10/30/1979SE |
Questions and answers
When was X-Vee cleared by the FDA?
X-Vee (K810152) received a 510(k) decision of Substantially Equivalent on March 17, 1981, 55 days after the submission was received.
What is the product code of K810152?
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.