510(k) K012991 ยท FYD Apparatus, Exhaust, Surgical
NEPTUNE WASTE MANAGEMENT STSTEM
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Nov 29, 2001 |
| Received | Sep 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012991
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2012 | Stryker Instruments Div. of Stryker Corporation Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover
IFU part 0700-001-700 Terminated |
FYD | None listed |
| Aug 15, 2012 | Stryker Instruments Div. of Stryker Corporation Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International)
Instructions For Use 0700-001-700, 0700-002-707
Intended for use in the surgical e Terminated |
FYD | None listed |
| Aug 15, 2012 | Stryker Instruments Div. of Stryker Corporation Stryker Neptune Bronze Rover, Part 0700-007-000
Neptune Bronze Rover Waste Management System Instructions For Use.
Intended for use in the surgical environment or physician's office to collect and di Terminated |
FYD | None listed |
| Aug 15, 2012 | Stryker Instruments Div. of Stryker Corporation Neptune Rover Waste Management System, Neptune 2 Ultra
Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. Terminated |
FYD | None listed |
| Nov 4, 2004 | Stryker Instruments Div. of Stryker Corporation Stryker brand Neptune waste management system, Neptune Rover, 20 amp plug; model 0700-001-000. Terminated |
FYD | None listed |
| Feb 1, 2003 | Stryker Instruments, Instruments Div. Stryker brand Neptune waste management system; model 711-27-1. Terminated |
FYD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.