510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K160275Substantially Equivalent

Fuse Endoscopic System with FuseBox Processor

Boston Scientific Corporation, Alpharetta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160275 is the FDA 510(k) clearance record for Fuse Endoscopic System with FuseBox Processor, a class II device, cleared for Endochoice, Inc. on under FDA product code PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement). FDA's definition for product code PEA reads: "Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement". FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K160275.

Clearance record

Decision date
Received
(181 days to decision)
Product code
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endochoice, Inc. 11810 Wills Rd., Alpharetta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEA

Trailing 12 months

FDA records hold no clearances under product code PEA in the trailing twelve months.

FDA records show no clearances under product code PEA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PEA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260