510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920431Substantially Equivalent

Omnitron Needle Applicators 18 and 21 Gauge

Omnitron Intl., Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920431 is the FDA 510(k) clearance record for OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE, a class II device, cleared for Omnitron Intl., Inc. on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list 7 510(k) clearances for Omnitron Intl., Inc., from to . As of , FDA records show no recalls naming K920431.

Clearance record

Decision date
Received
(116 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Omnitron Intl., Inc. 8990 Kirby, Suite 200, Houston TX
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