Disposable Vitrectomy Handpiece
FDA 510(k) K832235 · Innovative Surgical Products, Inc.
510(k) numberK832235
Submission
- Device name
- Disposable Vitrectomy Handpiece
- Applicant
- Innovative Surgical Products, Inc.
Walker, MI, US - Received
- July 11, 1983
- Decision date
- September 29, 1983
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K843041 | Heslin Dispos. Tubing SetHQE · Traditional | 11/21/1984SE |
| K840695 | Phacoemulsification KitsHQC · Traditional | 05/22/1984SE |
| K840693 | Disposable Scleral Globe PlugLXP · Traditional | 05/22/1984SE |
| K840694 | Lens Insertion GlideKYB · Traditional | 05/09/1984SE |
| K841072 | Irrigation, Aspiration Tubing SetsHQC · Traditional | 03/29/1984SE |
| K821496 | Disposable Irriga/Aspir. SystemKDH · Traditional | 06/22/1982SE |
| K820765 | Pleural Drainage ReservoirGCX · Traditional | 04/15/1982SE |
| K820680 | Disposable Tubing SetsKYG · Traditional | 04/09/1982SE |
| K802973 | Ispvac TMGCY · Traditional | 12/19/1980SE |
| K801350 | Acuvac(Tm) Suction Reservoir 400CC andGCY · Traditional | 07/14/1980SE |
Questions and answers
When was Disposable Vitrectomy Handpiece cleared by the FDA?
Disposable Vitrectomy Handpiece (K832235) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 80 days after the submission was received.
What is the product code of K832235?
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.