510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K943109Substantially Equivalent

Remote Control Radioisotope Applicator

Inter-Pal GmbH, Palos Verdes Estates CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943109 is the FDA 510(k) clearance record for REMOTE CONTROL RADIOISOTOPE APPLICATOR, a class II device, cleared for Inter-Pal GmbH on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list one 510(k) clearance for Inter-Pal GmbH. As of , FDA records show no recalls naming K943109.

Clearance record

Decision date
Received
(225 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Inter-Pal GmbH 2228 Via La Brea, Palos Verdes Estates CA
510(k) summary
Statement
Third party review
No

Clearances, product code JAQ

Trailing 12 months
4 clearances under product code JAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260