Power-Load Cot Fastener System
FDA 510(k) K113598 · Stryker Medical
510(k) numberK113598
Submission
- Device name
- Power-Load Cot Fastener System
- Applicant
- Stryker Medical
Portage, MI, US - Received
- December 5, 2011
- Decision date
- December 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FPO – Stretcher, Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6910
- Specialty
- General Hospital
Other 510(k)s with product code FPO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072598 | Irsg I-Mover for BedsFPO · Traditional | International Retail Services Group, LLC | 04/14/2008SE |
| K972528 | Dyna Glide 2600 Roll-In Ambulance Cot (95759)FPO · Traditional | Dyna Corp. | 07/28/1997SE |
| K955766 | Adult-Pediatric Transport SystemFPO · Traditional | International Biomedical, Inc. | 08/07/1996SE |
| K962181 | Hare Model 2000 Ez Loader Model 95555FPO · Traditional | Dyna Corp. | 08/01/1996SE |
| K961437 | Wheeled StretcherFPO · Traditional | Hill-Rom, Inc. | 06/03/1996SE |
| K952447 | Hill-Rom Ambulatory Care Procedural StretcherFPO · Traditional | Hill-Rom, Inc. | 11/22/1995SE |
| K946101 | Emergency/Accident Trolley 550FPO · Traditional | Hogan & Hartson | 02/07/1995SE |
| K945431 | Model 792 Converge, Model 793 Vision 2000FPO · Traditional | Hausted, Inc. | 01/25/1995SE |
| K943969 | Model 578 Mobile Surgical StretcherFPO · Traditional | Hausted, Inc. | 01/25/1995SE |
| K942948 | Stryker Powered StretcherFPO · Traditional | Stryker Corp. | 01/24/1995SE |
More from Stryker Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K222818 | Xpedition Powered Stair Chair (625700000000)ILK · Traditional | 01/24/2023SE |
| K180834 | Altrix Precision Temperature Management SystemDWJ · Traditional | 08/10/2018SE |
| K171149 | Altrix Temperature Management WrapsDWJ · Traditional | 07/18/2017SE |
| K152266 | Altrix Precision Temperature Management SystemDWJ · Traditional | 12/02/2016SE |
| K946149 | Stryker Agility Intensive Care BedFNL · Traditional | 03/14/1995SE |
| K943864 | Stryker 8000 Surgery StretcherFPO · Traditional | 08/25/1994SE |
| K935949 | Stryker 5000FNM · Traditional | 06/17/1994SE |
| K941738 | Stryker 5050 StrechairINM · Traditional | 05/06/1994SE |
| K940068 | Stryker Operating Room TableFQO · Traditional | 05/05/1994SE |
| K935297 | Stryker Ambulance Cot Model 6060FPO · Traditional | 02/18/1994SE |
Questions and answers
When was Power-Load Cot Fastener System cleared by the FDA?
Power-Load Cot Fastener System (K113598) received a 510(k) decision of Substantially Equivalent on December 20, 2011, 15 days after the submission was received.
What is the product code of K113598?
The FDA product code is FPO – Stretcher, Wheeled, a Class II (moderate risk) device regulated under 21 CFR 880.6910.