510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K845006Substantially Equivalent

Sun Medical Laminaria Cervical Dilator

Sun Medical Co., Ltd., Arlington TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K845006 is the FDA 510(k) clearance record for SUN MEDICAL LAMINARIA CERVICAL DILATOR, a class II device, cleared for Sun Medical, Inc. on under FDA product code HDY (Dilator, Cervical, Hygroscopic-Laminaria). FDA records list 6 510(k) clearances for Sun Medical, Inc., from to . As of , FDA records show no recalls naming K845006.

Clearance record

Decision date
Received
(126 days to decision)
Product code
HDY Dilator, Cervical, Hygroscopic-Laminaria
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sun Medical, Inc. 1179 Corporate Dr. W., #100, Arlington TX
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