510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040625Substantially Equivalent

Atad Ard Catheter

Atad Developments, Ltd., Haifa, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040625 is the FDA 510(k) clearance record for ATAD ARD CATHETER, a class II device, cleared for Atad Developments , Ltd. on under FDA product code HDY (Dilator, Cervical, Hygroscopic-Laminaria). FDA records list one 510(k) clearance for Atad Developments , Ltd. As of , FDA records show no recalls naming K040625.

Clearance record

Decision date
Received
(315 days to decision)
Product code
HDY Dilator, Cervical, Hygroscopic-Laminaria
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Atad Developments , Ltd. 70 Yakinton St., Haifa, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HDY

Trailing 12 months

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

FDA records show no clearances under product code HDY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HDY, 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