510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K955668Substantially Equivalent

Intracavity Needle Guide Kit

Arlanda Medicinska Instrument Co. AB, 191 47 Sollentuna, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955668 is the FDA 510(k) clearance record for INTRACAVITY NEEDLE GUIDE KIT, a class II device, cleared for Arlanda Medicinska Instrument Co. AB on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list one 510(k) clearance for Arlanda Medicinska Instrument Co. AB. As of , FDA records show no recalls naming K955668.

Clearance record

Decision date
Received
(595 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Arlanda Medicinska Instrument Co. AB Turebergsvagen 5, 191 47 Sollentuna, SE
510(k) summary
Statement
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