510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040189Substantially Equivalent

Endometrial Sampling Syringe

Rocket Medical, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040189 is the FDA 510(k) clearance record for ENDOMETRIAL SAMPLING SYRINGE, a class II device, cleared for Rocket Medical Plc on under FDA product code HHK (Curette, Suction, Endometrial (And Accessories)). FDA records list 19 510(k) clearances for Rocket Medical Plc, from to . As of , FDA records show no recalls naming K040189.

Clearance record

Decision date
Received
(250 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
Rocket Medical Plc 1151 Hope St., Stamford CT
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