Irrigation & Aspiration/Vitrectomy Device
FDA 510(k) K862188 · Coburn Optical Ind., Inc.
510(k) numberK862188
Submission
- Device name
- Irrigation & Aspiration/Vitrectomy Device
- Applicant
- Coburn Optical Ind., Inc.
Clearwater, FL, US - Received
- June 9, 1986
- Decision date
- August 21, 1986
- 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
Other 510(k)s with product code HQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212763 | UniVit HE, UniVit UHSHQE · Traditional | Visioncare Devices, LLC | 08/10/2022SE |
| K170183 | Cetus system, Cetus probeHQE · Traditional | A.R.C Laser GmbH | 09/27/2017SE |
| K153168 | Bi-Blade Vitrectomy CutterHQE · Special | Medical Instrument Development Laboratories | 04/29/2016SE |
| K141065 | Constellation Vision SystemHQE · Traditional | Alcon Research, Ltd. | 08/22/2014SE |
| K121675 | VersavitHQE · Traditional | Synergetics, Inc. | 06/21/2012SE |
| K120170 | Procare Plus Vitrectomy SystemHQE · Traditional | Visioncare Devices, Inc. | 05/30/2012SE |
| K102222 | Ultimate Vit Enhamcer (Uve)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/08/2011SE |
| K033390 | Colibri Disposable Vitrectomy CutterHQE · Traditional | Microworld Medical Instruments, Inc. | 11/04/2003SE |
| K030948 | Vmate Model VMM1000HQE · Traditional | Howard Instruments, Inc. | 06/17/2003SE |
| K023939 | Velocity AdvantageHQE · Traditional | Visioncare Devices, Inc. | 04/17/2003SE |
More from Visioncare Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K892351 | Magnilink System 602HJG · Traditional | 05/26/1989SE |
| K892350 | Magnilink System 402/5HJG · Traditional | 05/26/1989SE |
| K892349 | Magnilink System 209HJG · Traditional | 05/26/1989SE |
| K892348 | Magnilink System 201HJG · Traditional | 05/26/1989SE |
| K892347 | Magnilink System 101HJG · Traditional | 05/26/1989SE |
| K853457 | Coburn I/A SystemHQE · Traditional | 10/15/1985SE |
| K821737 | Disp. Microsurgical KnivesGES · Traditional | 07/02/1982SE |
| K812441 | Di-CrownHQG · Traditional | 10/06/1981SE |
| K803159 | Automated PerimetersHPT · Traditional | 02/04/1981SE |
| K801659 | Biophtal Clinical Endothelial MicroscopeHJO · Traditional | 09/09/1980SE |
Questions and answers
When was Irrigation & Aspiration/Vitrectomy Device cleared by the FDA?
Irrigation & Aspiration/Vitrectomy Device (K862188) received a 510(k) decision of Substantially Equivalent on August 21, 1986, 73 days after the submission was received.
What is the product code of K862188?
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.