Cleared Traditional

Endoscopic Video Image Processor, Single-Use Video Hysteroscope (K232003) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232003 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Obstetrics & Gynecology device
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Feb 2024
Decision
221d
Days
Class 2
Risk

K232003 is an FDA 510(k) clearance for the Endoscopic Video Image Processor, Single-Use Video Hysteroscope. 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 February 12, 2024 after a review of 221 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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

Submission Details

510(k) Number K232003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2023
Decision Date February 12, 2024
Days to Decision 221 days
Submission Type Traditional
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
61d slower than avg
Panel avg: 160d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 93
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K232003.
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241987 · Guangzhou Red Pine Medical Instrument 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
HTx Disposable Hysteroscope System
K231260 · Suzhou AcuVu Medical Technology Co., Ltd. · Mar 2024
SPY Cystoscope/Hysteroscope
K233635 · Stryker Endoscopy · Feb 2024
Benesta Tissue Removal Device
K233500 · Caldera Medical, Inc. · Nov 2023
HOPKINS Telescopes
K223885 · KARL STORZ Endoscopy-America, Inc. · Sep 2023