510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083667Substantially Equivalent

Needle Guide for 8814, Model Ua1335, Needle Guide for 8815, Model Ua 1336, Needle Guide for 8824, Model Ua 1337

BK Medical ApS, Herlev, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083667 is the FDA 510(k) clearance record for NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337, a class II device, cleared for B-K Medical Aps on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 27 510(k) clearances for BK MEDICAL APS, from to . As of , FDA records show no recalls naming K083667.

Clearance record

Decision date
Received
(53 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
B-K Medical Aps Mileparken 34, Herlev, DK
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 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