Keates I/A System Frigitronics 4000
FDA 510(k) K822599 · Frigitronics of Connecticut, Inc.
510(k) numberK822599
Submission
- Device name
- Keates I/A System Frigitronics 4000
- Applicant
- Frigitronics of Connecticut, Inc.
Walker, MI, US - Received
- August 27, 1982
- Decision date
- October 6, 1982
- 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 |
| 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 |
| K791898 | Ocutome Model 8000HKP · Traditional | Cooper Medical Devices Corp. | 10/30/1979SE |
More from Cooper Medical Devices Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K891282 | MIC-100 with CryoprobesGEH · Traditional | 06/15/1989SE |
| K872362 | Frigitronics ACC-1000 Capsule CutterHQC · Traditional | 07/27/1987SE |
| K853308 | Keates Irrigation/Aspiration/Vitreous Cutter 5000HQE · Traditional | 10/04/1985SE |
| K834577 | I/A Probe Lines · Traditional | 05/22/1984SE |
| K840536 | Cryo Surg 5900GEH · Traditional | 04/23/1984SE |
| K834437 | Keates Irrigation/Aspiration/VitreousHQE · Traditional | 03/30/1984SE |
| K811390 | CCS100 Cryosurgical SystemGEH · Traditional | 06/16/1981SE |
| K760742 | CS-76 And/Or Cryocare IGEH · Traditional | 11/03/1976SE |
Questions and answers
When was Keates I/A System Frigitronics 4000 cleared by the FDA?
Keates I/A System Frigitronics 4000 (K822599) received a 510(k) decision of Substantially Equivalent on October 6, 1982, 40 days after the submission was received.
What is the product code of K822599?
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.