Cleared Traditional

RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)

K240434 · Li Medical Corporation , Ltd. · Obstetrics & Gynecology
Sep 2024
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K240434 is an FDA 510(k) clearance for the RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6), a Curette, Suction, Endometrial (and Accessories) (Class II — Special Controls, product code HHK), submitted by Li Medical Corporation , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on September 25, 2024, 224 days after receiving the submission on February 14, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1175.

Submission Details

510(k) Number K240434 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2024
Decision Date September 25, 2024
Days to Decision 224 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HHK — Curette, Suction, Endometrial (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1175

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