POWER-LOAD COT FASTENER SYSTEM
FDA 510(k) clearance K113598 · decided 2011-12-20
Clearance details
- K-number
- K113598
- Device name
- POWER-LOAD COT FASTENER SYSTEM
- Applicant
- Stryker Medical
- Decision
- Substantially Equivalent
- Date received
- 2011-12-05
- Decision date
- 2011-12-20
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FPO
- Device class
- 2
- Regulation number
- 880.6910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Portage, MI, US
- Third-party review
- Yes
- 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 |
|---|---|---|
| IRSG I-MOVER FOR BEDS (K072598) | International Retail Services Group, LLC | 2008-04-14 |
| DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) (K972528) | Dyna Corp. | 1997-07-28 |
| ADULT-PEDIATRIC TRANSPORT SYSTEM (K955766) | International Biomedical, Inc. | 1996-08-07 |
| HARE MODEL 2000 EZ LOADER MODEL 95555 (K962181) | Dyna Corp. | 1996-08-01 |
| WHEELED STRETCHER (K961437) | Hill-Rom, Inc. | 1996-06-03 |
| HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (K952447) | Hill-Rom, Inc. | 1995-11-22 |
| EMERGENCY/ACCIDENT TROLLEY 550 (K946101) | Hogan & Hartson | 1995-02-07 |
| MODEL 792 CONVERGE, MODEL 793 VISION 2000 (K945431) | Hausted, Inc. | 1995-01-25 |
| MODEL 578 MOBILE SURGICAL STRETCHER (K943969) | Hausted, Inc. | 1995-01-25 |
| STRYKER POWERED STRETCHER (K942948) | Stryker Corp. | 1995-01-24 |
| PATIENT TROLLEY 545 (K943528) | Merivaara Instrumentarium Corp. | 1994-10-04 |
| PATIENT TROLLEY 540 (K943529) | Merivaara Instrumentarium Corp. | 1994-10-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 recall (Z-1350-2019) | Stryker Medical Division of Stryker Corporation | 2019-05-15 |
| Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 P recall (Z-1389-2018) | Stryker Medical Division of Stryker Corporation | 2018-05-01 |
| The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lif recall (Z-0566-2013) | Stryker Medical Division of Stryker Corporation | 2012-12-19 |