Cleared Special

K241987 - Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241987 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
25d
Days
Class 2
Risk

K241987 is an FDA 510(k) clearance for the Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101). Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Guangzhou Red Pine Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 2, 2024 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Guangzhou Red Pine Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K241987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d faster than avg
Panel avg: 160d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 168
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K241987.
InnovexView (GC146-17, GC150-20, GC155-23)
K254251 · Shanghai AnQing Medical Instrument Co., Ltd. · Feb 2026
ARMI® Endoscopic Video Image Processor (JY-MIP-3000)
K252793 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Dec 2025
SPY Cystoscope/Hysteroscope
K252012 · Stryker Endoscopy · Jul 2025
RZ Resectoscope System
K243382 · Rz Medizintechnik GmbH · Jun 2025
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
K240978 · MacroLux Medical Technology Co., Ltd. · Aug 2024
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
K240401 · Origyn Medical Technology (Hangzhou) Co., Ltd. · Jul 2024