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
K982725Substantially Equivalent

Olympus Mh-246R Balloon Sheath, for Female Reproductive Tract Use

OLYMPUS Corporation of the Americas, Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982725 is the FDA 510(k) clearance record for OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE, a class II device, cleared for Olympus America, Inc. on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show no recalls naming K982725.

Clearance record

Decision date
Received
(79 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Summary
Third party review
No

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260