Bi-Blade Vitrectomy Cutter
FDA 510(k) K153168 · Medical Instrument Development Laboratories
510(k) numberK153168
Submission
- Device name
- Bi-Blade Vitrectomy Cutter
- Applicant
- Medical Instrument Development Laboratories
San Leandro, CA, US - Received
- November 2, 2015
- Decision date
- April 29, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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
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| K170183 | Cetus system, Cetus probeHQE · Traditional | A.R.C Laser GmbH | 09/27/2017SE |
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| 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 |
| K020911 | Mid Labs Autonomous Vit Enhancer (Ave)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/29/2002SE |
More from Medical Instrument Development Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K932669 | Supra-Vit(Tm)HQE · Traditional | 06/03/1994SE |
| 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 Bi-Blade Vitrectomy Cutter cleared by the FDA?
Bi-Blade Vitrectomy Cutter (K153168) received a 510(k) decision of Substantially Equivalent on April 29, 2016, 179 days after the submission was received.
What is the product code of K153168?
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.