510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810503Substantially Equivalent

Flexible Choledochoscope/nephroscope

Olympus Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810503 is the FDA 510(k) clearance record for FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE, a class II device, cleared for Olympus Corp. on under FDA product code NWS (Kit, Choledochoscope, Flexible And Rigid). FDA's definition for product code NWS reads: "Flexible and Rigid Choledochoscope Kit". FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K810503.

Clearance record

Decision date
Received
(38 days to decision)
Product code
NWS Kit, Choledochoscope, Flexible And Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code NWS

Trailing 12 months

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

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