Cleared Traditional

K003802 - HYSTEROSCOPES (FDA 510(k) Clearance)

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

K003802 · Global Endoscopy, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
226d
Days
Class 2
Risk

K003802 is an FDA 510(k) clearance for the HYSTEROSCOPES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Global Endoscopy, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 22, 2001 after a review of 226 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 Global Endoscopy, Inc. devices

Submission Details

510(k) Number K003802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2000
Decision Date July 22, 2001
Days to Decision 226 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 160d · This submission: 226d
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 168
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K003802.
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
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241987 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Aug 2024