510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K973184Substantially Equivalent

Prostate Seeding Needle

Promex, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973184 is the FDA 510(k) clearance record for PROSTATE SEEDING NEEDLE, a class I device, cleared for Promex, Inc. on under FDA product code IWJ (System, Applicator, Radionuclide, Manual). FDA records list 18 510(k) clearances for Promex, Inc., from to . As of , FDA records show no recalls naming K973184.

Clearance record

Decision date
Received
(88 days to decision)
Product code
IWJ System, Applicator, Radionuclide, Manual
Regulation
21 CFR 892.5650
Device class
Class I
Review panel
Radiology
Applicant
Promex, Inc. 1125 Brookside Ave., Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code IWJ

Trailing 12 months

FDA records hold no clearances under product code IWJ in the trailing twelve months.

FDA records show no clearances under product code IWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260