510(k) K980488 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
| Applicant | Storz Instrument Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 23, 1998 |
| Received | Feb 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980488
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2007 | Bausch & Lomb Inc Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per package. The firm name on the label is Bausch & Lomb incorporated, Rochester, NY. Terminated |
HQE | None listed |
| May 24, 2007 | Bausch & Lomb Inc Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also in Terminated |
HQE | None listed |
| Apr 21, 2007 | Bausch & Lomb Inc Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Terminated |
HQE | None listed |
| Apr 21, 2007 | Bausch & Lomb Inc Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX. The firm names on the label are Bausch & Lomb Inco Terminated |
HQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.