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510(k) K240434

RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) by Li Medical Corporation , Ltd. — Product Code HHK

K240434 is an FDA 510(k) premarket notification submitted by Li Medical Corporation , Ltd. for the device "RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)". The FDA issued a decision of Substantially Equivalent on September 25, 2024. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Li Medical Corporation , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2024
Date Received
February 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Suction, Endometrial (And Accessories)
Device Class
Class II
Regulation Number
884.1175
Review Panel
OB
Submission Type

Other clearances by Li Medical Corporation , Ltd.

  • K252260 — RELIEEV HSG Catheter (HSG7FA1) (November 26, 2025)
  • K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0) (October 16, 2024)

Other clearances for product code HHK

  • K251882 — Uterine Aspiration Set (October 16, 2025)
  • K201952 — CrossGlide ETS Plus (August 5, 2020)
  • K192534 — CrossBay Endometrial Tissue Sampler (ETS) (March 25, 2020)
  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (April 14, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 2004)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (April 8, 2003)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)

FDA data resources