510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021012Substantially Equivalent

Laminaria 2Mm/3mm/4mm/5mm/6mm/7mm/8mm/9mm

Quality Medical Solusions, LLC, Alpharetta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021012 is the FDA 510(k) clearance record for LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM, a class II device, cleared for Quality Medical Solusions, LLC on under FDA product code HDY (Dilator, Cervical, Hygroscopic-Laminaria). FDA records list one 510(k) clearance for Quality Medical Solusions, LLC. As of , FDA records show no recalls naming K021012.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HDY Dilator, Cervical, Hygroscopic-Laminaria
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Quality Medical Solusions, LLC 1308 Morningside Park Dr., Alpharetta GA
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