510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962365Substantially Equivalent

Xenon Lightsource

Dsp Worldwide, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962365 is the FDA 510(k) clearance record for XENON LIGHTSOURCE, a class II device, cleared for Dsp Worldwide on under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list 3 510(k) clearances for Dsp Worldwide, from to . As of , FDA records show no recalls naming K962365.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GCT Light Source, Endoscope, Xenon Arc
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dsp Worldwide 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code GCT

Trailing 12 months

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

FDA records show no clearances under product code GCT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCT, 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