REUSABLE VITRECTOMY PROBE
FDA 510(k) clearance K970670 · decided 1997-05-06
Clearance details
- K-number
- K970670
- Device name
- REUSABLE VITRECTOMY PROBE
- Applicant
- Altex Vision
- Decision
- Substantially Equivalent
- Date received
- 1997-02-24
- Decision date
- 1997-05-06
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- HQE
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UniVit HE, UniVit UHS (K212763) | Visioncare Devices, LLC | 2022-08-10 |
| Cetus system, Cetus probe (K170183) | A.R.C Laser GmbH | 2017-09-27 |
| Bi-Blade Vitrectomy Cutter (K153168) | Medical Instrument Development Laboratories | 2016-04-29 |
| CONSTELLATION VISION SYSTEM (K141065) | Alcon Research, Ltd. | 2014-08-22 |
| VERSAVIT (K121675) | Synergetics, Inc. | 2012-06-21 |
| PROCARE PLUS VITRECTOMY SYSTEM (K120170) | Visioncare Devices, Inc. | 2012-05-30 |
| ULTIMATE VIT ENHAMCER (UVE) (K102222) | Medical Instrument Development Laboratories, Inc. | 2011-04-08 |
| COLIBRI DISPOSABLE VITRECTOMY CUTTER (K033390) | Microworld Medical Instruments, Inc. | 2003-11-04 |
| VMATE MODEL VMM1000 (K030948) | Howard Instruments, Inc. | 2003-06-17 |
| VELOCITY ADVANTAGE (K023939) | Visioncare Devices, Inc. | 2003-04-17 |
| MID LABS AUTONOMOUS VIT ENHANCER (AVE) (K020911) | Medical Instrument Development Laboratories, Inc. | 2002-04-29 |
| D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (K010082) | Dutch Ophthalmic USA, Inc. | 2001-03-12 |
Recalls involving this device
No recalls on record reference this clearance.