Cleared Traditional

K232003 - Endoscopic Video Image Processor

K232003 is an FDA 510(k) clearance for Endoscopic Video Image Processor, manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K232003 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K232003

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.

HIH Device Classification - Class 2, Special Controls

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 109
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