510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K251882Substantially Equivalent

Uterine Aspiration Set

Gcmedica Enterprise Ltd. (Wuxi), Wuxi, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251882 is the FDA 510(k) clearance record for Uterine Aspiration Set, a class II device, cleared for Gcmedica Enterprise Ltd.(Wuxi) on under FDA product code HHK (Curette, Suction, Endometrial (And Accessories)). FDA records list 2 510(k) clearances for Gcmedica Enterprise Ltd.(Wuxi), from to . As of , FDA records show no recalls naming K251882.

Clearance record

Decision date
Received
(118 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
Gcmedica Enterprise Ltd.(Wuxi) 18 Xinjin Rd., Xinwu Industrial Zone, Wuxi, CN
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