Cleared Traditional

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) (K213171) - FDA 510(k) Clearance

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

K213171 · Meditrina, Inc. · Obstetrics & Gynecology device
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May 2022
Decision
240d
Days
Class 2
Risk

K213171 is an FDA 510(k) clearance for the Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposa.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Meditrina, Inc. (San Jose, US). The FDA issued a Cleared decision on May 26, 2022 after a review of 240 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 Meditrina, Inc. devices

Submission Details

510(k) Number K213171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2021
Decision Date May 26, 2022
Days to Decision 240 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
80d slower than avg
Panel avg: 160d · This submission: 240d
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 K213171.
Aveta System 2.0
K223813 · Meditrina, Inc. · Aug 2023
UNIDRIVE SIII System
K223520 · KARL STORZ Endoscopy-America, Inc. · Apr 2023
Visera Hysterovideoscope Olympus HYF Type V
K221557 · Olympus Medical Systems Corporation · Sep 2022
Sheath, Stopcock Accessory
K213207 · Olympus Winter & Ibe GmbH · Dec 2021
Hystero-V Hysteroscope
K202445 · Hysterovue, Inc. · Nov 2021
Medical Endoscope Image Processing System
K210270 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Oct 2021