510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113120Substantially Equivalent

Chf-Y0005

Olympus Medical Systems Corp., Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113120 is the FDA 510(k) clearance record for CHF-Y0005, a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code FBN (Choledochoscope And Accessories, Flexible/Rigid). FDA's definition for product code FBN reads: "to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show no recalls naming K113120.

Clearance record

Decision date
Received
(340 days to decision)
Product code
FBN Choledochoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corp. 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FBN

Trailing 12 months
3 clearances under product code FBN in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FBN, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260