120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
FDA 510(k) clearance K222552 · decided 2022-12-09
Clearance details
- K-number
- K222552
- Device name
- 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2022-08-23
- Decision date
- 2022-12-09
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Portage, MI, US
- Third-party review
- No
- Expedited review
- No
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| Acare Suction Unit (K182950) | Acare Technology Co., Ltd. | 2019-08-23 |
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| ZOOM Aspiration Pump (K190105) | Taiwan Biomaterial Co., Ltd. | 2019-02-21 |
| TWBM Pump (K180115) | Taiwan Biomaterial Co., Ltd. | 2018-07-24 |
| DV-300 Aspirator (K181398) | Ding Hwa Co., Ltd. | 2018-07-23 |
| IntelliCart System (K172481) | Dornoch Medical Systems | 2017-09-14 |
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Recalls involving this device
No recalls on record reference this clearance.