Fuse Endoscopic System with FuseBox Processor
FDA 510(k) K160275 · Endochoice, Inc.
510(k) numberK160275
Submission
- Device name
- Fuse Endoscopic System with FuseBox Processor
- Applicant
- Endochoice, Inc.
Alpharetta, GA, US - Received
- February 2, 2016
- Decision date
- August 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEA – Endoscope, Accessories, Image Post-Processing For Color Enhancement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
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Questions and answers
When was Fuse Endoscopic System with FuseBox Processor cleared by the FDA?
Fuse Endoscopic System with FuseBox Processor (K160275) received a 510(k) decision of Substantially Equivalent on August 1, 2016, 181 days after the submission was received.
What is the product code of K160275?
The FDA product code is PEA – Endoscope, Accessories, Image Post-Processing For Color Enhancement, a Class II (moderate risk) device regulated under 21 CFR 876.1500.