STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
FDA 510(k) clearance K954340 · decided 1995-12-14
Clearance details
- K-number
- K954340
- Device name
- STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
- Applicant
- Storz
- Decision
- Substantially Equivalent
- Date received
- 1995-09-18
- Decision date
- 1995-12-14
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bausch & Lomb MicroFlow 30 Phaco Needle, Model DP8230S, 6 pouches/box. The firm name on th recall (Z-1725-2010) | Bausch & Lomb Inc | 2010-05-28 |
| Bausch & Lomb MicroFlow 45 Phaco Needle, Model DP8245S, 6 pouches/box. The firm name on th recall (Z-1726-2010) | Bausch & Lomb Inc | 2010-05-28 |
| Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The firm name recall (Z-1727-2010) | Bausch & Lomb Inc | 2010-05-28 |
| Bausch & Lomb MicroFlow 2.2 30 Phaco Needle, Model DP8730S, 6 pouches/box. The firm name o recall (Z-1730-2010) | Bausch & Lomb Inc | 2010-05-28 |
| Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile recall (Z-1279-03) | Bausch & Lomb Incorporated | 2003-10-15 |