Cleared Special

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)

K241987 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Obstetrics & Gynecology
Aug 2024
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K241987 is an FDA 510(k) clearance for the Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101), a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Guangzhou Red Pine Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 2, 2024, 25 days after receiving the submission on July 8, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K241987 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2024
Decision Date August 02, 2024
Days to Decision 25 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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