Keates Irrigation/Aspiration/Vitreous
FDA 510(k) K834437 · Frigitronics of Connecticut, Inc.
510(k) numberK834437
Submission
- Device name
- Keates Irrigation/Aspiration/Vitreous
- Applicant
- Frigitronics of Connecticut, Inc.
Walker, MI, US - Received
- December 19, 1983
- Decision date
- March 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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More from Visioncare Devices, Inc.
| 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 |
| K822599 | Keates I/A System Frigitronics 4000HKP · Traditional | 10/06/1982SE |
| 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 Irrigation/Aspiration/Vitreous cleared by the FDA?
Keates Irrigation/Aspiration/Vitreous (K834437) received a 510(k) decision of Substantially Equivalent on March 30, 1984, 102 days after the submission was received.
What is the product code of K834437?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.