510(k) K241987

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) by Guangzhou Red Pine Medical Instrument Co., Ltd. — Product Code HIH

K241987 is an FDA 510(k) premarket notification submitted by Guangzhou Red Pine Medical Instrument Co., Ltd. for the device "Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)". The FDA issued a decision of Substantially Equivalent on August 2, 2024. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Guangzhou Red Pine Medical Instrument Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2024
Date Received
July 8, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type