--- title: IH 510(k) Process White Paper --- [![Innovative Health](https://info.innovative-health.com/hubfs/Innovative_Health_September2017/Images/IH-H-4C_site-header.png "Innovative Health")](http://innovative-health.com/) - Devices - [Diagnostic Ultrasound Catheters](http://innovative-health.com/devices/diagnostic-ultrasound-catheters/) - [Diagnostic Electrophysiology (EP) Catheters](http://innovative-health.com/devices/diagnostic-electrophysiology-ep-catheters/) - [Reprocessing](http://innovative-health.com/reprocessing/) - [How It Works](http://innovative-health.com/how-it-works/) - Resources - [IFUs](http://innovative-health.com/ifus/) - [Calculator](http://innovative-health.com/calculator/) - Documentation - [Articles](http://innovative-health.com/articles/) - [Reports](http://innovative-health.com/reports/) - [News](http://innovative-health.com/news/) - [Careers](http://innovative-health.com/careers/) # Developing a 510(k) to achieve FDA Clearance for Reprocessing of Single-Use Devices   Hi there - thanks for your interest in the *Developing a 510(k) to achieve FDA Clearance for Reprocessing of Single-Use Devices* white paper! To reprocess and sell a single-use medical device, a reprocessor must submit a 510(k) application to FDA and receive a clearance for that device. The submission process is highly formalized. However, leading up to the submission are months of technical development in reverse engineering and testing. This white paper describes not only the 510(k) process, but also the engineering process involved in compiling and submitting a 510(k). Click the link below to download the full report and find out more! ##### Innovative Health Innovative Health was founded by reprocessing pioneers to take reprocessing/remanufacturing to the next level: Optimizing financial impact through seamless processes. ##### Contact Info 1435 North Hayden Road, Suite 100, Scottsdale, AZ 85257 Phone: 877.400.3740Email: [info@innovative-health.com](mailto:info@innovative-health.com) 2019 © Innovative Health. \*\*This site last updated on January 11, 2019\*\* [IFUs](http://innovative-health.com/ifus/)