510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011512Substantially Equivalent

Mmodification to Laminaria

A & A Medical, Inc., Alpharetta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011512 is the FDA 510(k) clearance record for MMODIFICATION TO LAMINARIA, a class II device, cleared for A & A Medical, Inc. on under FDA product code HDY (Dilator, Cervical, Hygroscopic-Laminaria). FDA records list 23 510(k) clearances for A & A Medical, Inc., from to . As of , FDA records show no recalls naming K011512.

Clearance record

Decision date
Received
(54 days to decision)
Product code
HDY Dilator, Cervical, Hygroscopic-Laminaria
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
A & A Medical, Inc. 9370 Industrial Trace, Alpharetta GA
510(k) summary
Summary
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