Cleared Traditional

K202445 - Hystero-V Hysteroscope (FDA 510(k) Clearance)

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

K202445 · Hysterovue, Inc. · Obstetrics & Gynecology device
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Nov 2021
Decision
454d
Days
Class 2
Risk

K202445 is an FDA 510(k) clearance for the Hystero-V Hysteroscope. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Hysterovue, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 23, 2021 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Hysterovue, Inc. devices

Submission Details

510(k) Number K202445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2020
Decision Date November 23, 2021
Days to Decision 454 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
294d slower than avg
Panel avg: 160d · This submission: 454d
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 K202445.
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