510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K123424Substantially Equivalent

Mdu5 Plus Sterile Bag

Boston Scientific Corporation, Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123424 is the FDA 510(k) clearance record for MDU5 PLUS STERILE BAG, a class II device, cleared for Boston Scientific Corp on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K123424.

Clearance record

Decision date
Received
(105 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Boston Scientific Corp 47215 Lakeview Blvd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ITX

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