510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963043Substantially Equivalent

Endospot

Corin USA, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963043 is the FDA 510(k) clearance record for ENDOSPOT, a class II device, cleared for Corin USA on under FDA product code FCW (Light Source, Fiberoptic, Routine). FDA records list 78 510(k) clearances for Corin USA, from to . As of , FDA records show no recalls naming K963043.

Clearance record

Decision date
Received
(46 days to decision)
Product code
FCW Light Source, Fiberoptic, Routine
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Corin USA 10500 University Center Dr., Tampa FL
510(k) summary
Summary
Third party review
No

Clearances, product code FCW

Trailing 12 months

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

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