Supra-Vit(Tm)
FDA 510(k) K932669 · Medical Instrument Development Laboratories, Inc.
510(k) numberK932669
Submission
- Device name
- Supra-Vit(Tm)
- Applicant
- Medical Instrument Development Laboratories, Inc.
San Leandro, CA, US - Received
- June 2, 1993
- Decision date
- June 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K153168 | Bi-Blade Vitrectomy CutterHQE · Special | 04/29/2016SE |
| K102222 | Ultimate Vit Enhamcer (Uve)HQE · Traditional | 04/08/2011SE |
| K020911 | Mid Labs Autonomous Vit Enhancer (Ave)HQE · Traditional | 04/29/2002SE |
| K992943 | Vit EnhancerHQE · Traditional | 12/10/1999SE |
| K971067 | Digi-InjectorMRH · Traditional | 09/19/1997SE |
| K950287 | Univit ProbeHKP · Traditional | 04/10/1995SE |
| K934600 | MicrodriveHQE · Traditional | 07/27/1994SE |
| K932131 | Mid Labs Twin IlluminatorEQH · Traditional | 04/01/1994SE |
| K924222 | Mid Labs, Inc. Vit MateHQE · Traditional | 01/27/1993SE |
| K851610 | Combined MVS SystemsHQE · Traditional | 07/22/1985SE |
Questions and answers
When was Supra-Vit(Tm) cleared by the FDA?
Supra-Vit(Tm) (K932669) received a 510(k) decision of Substantially Equivalent on June 3, 1994, 366 days after the submission was received.
What is the product code of K932669?
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.