STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER
FDA 510(k) clearance K940130 · decided 1994-03-10
Clearance details
- K-number
- K940130
- Device name
- STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-03
- Decision date
- 1994-03-10
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- FPP
- Device class
- 1
- Regulation number
- 880.6900
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BABY POD (K030283) | Prism Enterprises, Inc. | 2003-04-22 |
| MED-EVAC-4 MEDICAL EVACUATION STRETCHER (K942356) | Montery Bay Corp. | 1994-07-19 |
| EVACU-SLED (K940245) | Evacu Technologies, Inc. | 1994-02-28 |
| RESTRAINING STRETCHER (K924275) | Dms | 1993-07-27 |
| U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER (K922816) | Up Custom Design, Inc. | 1993-07-13 |
| FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W (K924669) | Ferno | 1993-04-29 |
| LIFE LITE EMERGENCY STRETCHER (K920805) | Design Principles, Inc. | 1992-05-22 |
| BASKET LITTER CARRIER (K915874) | Bradco Med , Ltd. | 1992-05-13 |
| GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED (K914140) | Bissell Medical Products, Inc. | 1992-03-31 |
| EVACU SLED (K913520) | Nexus Health Care Products , Ltd. | 1991-12-04 |
| HAND CARRIED STRETCHER (K911765) | L.E. Phillips Career Development Center, Inc. | 1991-06-14 |
| RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM (K904237) | Innovative Medical Technologies, Inc. | 1991-05-09 |
Recalls involving this device
No recalls on record reference this clearance.
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 |