VISITEC VITRECTOMY UNIT
FDA 510(k) clearance K896622 · decided 1990-04-04
Clearance details
- K-number
- K896622
- Device name
- VISITEC VITRECTOMY UNIT
- Applicant
- Visitec Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-21
- Decision date
- 1990-04-04
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- HKP
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Visitec Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AARON VAC 2 (K952558) | Aaron Medical Industries | 1997-03-19 |
| THE GRIESHABER AXIAL CUTTER (K950056) | Grieshaber & Co. | 1995-05-05 |
| UNIVIT PROBE (K950287) | Medical Instrument Development Laboratories, Inc. | 1995-04-10 |
| MENTOR ANTERIOR SEGMENT VITRECTOR (K890595) | Mentor O & O, Inc. | 1989-04-17 |
| CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (K832074) | CooperVision, Inc. | 1983-08-01 |
| KEATES I/A SYSTEM FRIGITRONICS 4000 (K822599) | Frigitronics of Connecticut, Inc. | 1982-10-06 |
| EMERGENCY POWER PAC (EMPAC) (K813273) | Optical Micro Systems, Inc. | 1981-12-31 |
| X-VEE (K810152) | Temporaty Surgical Systems | 1981-03-17 |
| EYE-VAC (K801231) | Coburn Optical Ind., Inc. | 1980-07-21 |
| OCUTOME MODEL 8000 (K791898) | Cooper Medical Devices Corp. | 1979-10-30 |
| VITREOUS SUCTION/CUTTER (K791000) | Concept, Inc. | 1979-09-04 |
| STAT (K790893) | Varian Assoc., Inc. | 1979-08-28 |
Recalls involving this device
No recalls on record reference this clearance.