NEPTUNE WASTE MANAGEMENT STSTEM
FDA 510(k) clearance K012991 · decided 2001-11-29
Clearance details
- K-number
- K012991
- Device name
- NEPTUNE WASTE MANAGEMENT STSTEM
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2001-09-06
- Decision date
- 2001-11-29
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FYD
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700- recall (Z-2061-2012) | Stryker Instruments Div. of Stryker Corporation | 2012-08-15 |
| Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 07 recall (Z-2062-2012) | Stryker Instruments Div. of Stryker Corporation | 2012-08-15 |
| Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management Syst recall (Z-2063-2012) | Stryker Instruments Div. of Stryker Corporation | 2012-08-15 |
| Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical en recall (Z-2064-2012) | Stryker Instruments Div. of Stryker Corporation | 2012-08-15 |
| Stryker brand Neptune waste management system, Neptune Rover, 20 amp plug; model 0700-001- recall (Z-0174-05) | Stryker Instruments Div. of Stryker Corporation | 2004-11-04 |
| Stryker brand Neptune waste management system; model 711-27-1. recall (Z-0524-03) | Stryker Instruments, Instruments Div. | 2003-02-01 |