Cleared Traditional

Hystero-V Hysteroscope (K202445) - 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 93
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K202445.
Visera Hysterovideoscope Olympus HYF Type V
K221557 · Olympus Medical Systems Corporation · Sep 2022
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
K213171 · Meditrina, Inc. · May 2022
Sheath, Stopcock Accessory
K213207 · Olympus Winter & Ibe GmbH · Dec 2021
Medical Endoscope Image Processing System
K210270 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Oct 2021
HTx Disposable Hysteroscope System
K211227 · Acuvu, Inc. · Sep 2021
BenestaTM Tissue Removal Device
K192811 · Caldera Medical, Inc. · Oct 2020