STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
FDA 510(k) clearance K980488 · decided 1998-03-23
Clearance details
- K-number
- K980488
- Device name
- STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-09
- Decision date
- 1998-03-23
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- HQE
- Device class
- 2
- Regulation number
- 886.4150
- 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 Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high spe recall (Z-0495-2007) | Bausch & Lomb Inc | 2007-05-24 |
| Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, con recall (Z-0496-2007) | Bausch & Lomb Inc | 2007-05-24 |
| Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Cat recall (Z-0765-2007) | Bausch & Lomb Inc | 2007-04-21 |
| Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX49 recall (Z-0766-2007) | Bausch & Lomb Inc | 2007-04-21 |