PRISMA DISPOSABLE MICRO IRRIGATING VECTUS
FDA 510(k) clearance K874984 · decided 1988-04-13
Clearance details
- K-number
- K874984
- Device name
- PRISMA DISPOSABLE MICRO IRRIGATING VECTUS
- Applicant
- Advanced Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-02
- Decision date
- 1988-04-13
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- HMX
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chesterfield, MO, 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 |
|---|---|---|
| WEISS RETINAL CANNULA (K010305) | Micron Surgical, Inc. | 2001-05-02 |
| VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES (K000457) | Retinalabs.Com | 2000-05-09 |
| ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (K970873) | American Medical Devices, Inc. | 1997-05-20 |
| STERISEAL OPHTHALMIC CANNULA (K943932) | Pharma-Plast, Ltd. | 1995-01-18 |
| INFUSION CANNULA (K942403) | Microsurgical Technology, Inc. | 1994-08-17 |
| INTER TIP T (K934844) | Microsurgical Technology, Inc. | 1994-04-19 |
| KIRWAN IRRIGATION/ASPIRATION HANDPIECE (K930113) | Kirwan Surgical Products, Inc. | 1994-02-17 |
| ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (K921488) | Surgical Technologies, Inc. | 1992-05-07 |
| IRRIGATOR/ASPIRATOR PROBE (K915074) | Biomedical Dynamics, Inc. | 1992-02-05 |
| VITREORETINAL INFUSION CANNULA (K904074) | Visitec Co. | 1991-02-26 |
| OCULAR INFUSION CANNULA SYSTEM (K901618) | Tamcenan Corp. | 1990-05-31 |
| GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) (K890782) | Grieshaber & Co. | 1989-06-23 |
Recalls involving this device
No recalls on record reference this clearance.