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
K914825Substantially Equivalent

1-125 Endoseed

Endo Technic Corp., Omaha NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914825 is the FDA 510(k) clearance record for 1-125 ENDOSEED, a class II device, cleared for Endo Technic Corp. on under FDA product code KXK (Source, Brachytherapy, Radionuclide). FDA records list 10 510(k) clearances for Endo Technic Corp., from to . As of , FDA records show no recalls naming K914825.

Clearance record

Decision date
Received
(143 days to decision)
Product code
KXK Source, Brachytherapy, Radionuclide
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Endo Technic Corp. 4340 Leavenworth, Omaha NE
510(k) summary
Summary
Third party review
No

Clearances, product code KXK

Trailing 12 months
1 clearance under product code KXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260