510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021876Substantially Equivalent

Mas with or without Syringe

Marina Medical Instruments Inc., Alpharetta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021876 is the FDA 510(k) clearance record for MAS WITH OR WITHOUT SYRINGE, a class II device, cleared for Marina Medical Instruments, Inc. on under FDA product code HHK (Curette, Suction, Endometrial (And Accessories)). FDA records list 5 510(k) clearances for Marina Medical Instruments, Inc., from to . As of , FDA records show no recalls naming K021876.

Clearance record

Decision date
Received
(305 days to decision)
Product code
HHK Curette, Suction, Endometrial (And Accessories)
Regulation
21 CFR 884.1175
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Marina Medical Instruments, Inc. 1308 Morningside Park Dr., Alpharetta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HHK

Trailing 12 months

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

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