STRYKER POWERED WHEELED STRETCHER
FDA 510(k) clearance K022309 · decided 2002-11-08
Clearance details
- K-number
- K022309
- Device name
- STRYKER POWERED WHEELED STRETCHER
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-16
- Decision date
- 2002-11-08
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- INK
- Device class
- 2
- Regulation number
- 890.3690
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 1125 Prime Zoom Stryker Medical Stretcher A wheeled stretcher consists of a platform mount recall (Z-2926-2011) | Stryker Medical Division of Stryker Corporation | 2011-08-03 |
| Stryker Atlas Transport Stretcher with Zoom, Model 660Z, Stryker Medical, Portage, MI recall (Z-2183-2010) | Stryker Medical Div. of Stryker Corporation | 2010-08-09 |
| Stryker M-Series Stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI. recall (Z-2184-2010) | Stryker Medical Div. of Stryker Corporation | 2010-08-09 |
| Stryker Renaissance Series Stretchers, Model 1231Z Emergency Care with Zoom, Stryker Medic recall (Z-2185-2010) | Stryker Medical Div. of Stryker Corporation | 2010-08-09 |
| Stryker Renaissance Series Stretchers, Model 1731Z PACU with Zoom, Stryker Medical, Portag recall (Z-2186-2010) | Stryker Medical Div. of Stryker Corporation | 2010-08-09 |
| Stryker power cord kits, Stryker Medical, Portage, MI. recall (Z-2187-2010) | Stryker Medical Div. of Stryker Corporation | 2010-08-09 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |