Cleared Special

Aveta System (K191958) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191958 · Meditrina, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
70d
Days
Class 2
Risk

K191958 is an FDA 510(k) clearance for the Aveta System. 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 October 1, 2019 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Meditrina, Inc. devices

Submission Details

510(k) Number K191958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2019
Decision Date October 01, 2019
Days to Decision 70 days
Submission Type Special
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
90d faster than avg
Panel avg: 160d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 K191958.
Aveta Disposable Hysteroscope
K192100 · Meditrina, Inc. · Dec 2019
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
K190797 · Reed Medical (Zhejiang) Co., Ltd. · Nov 2019
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
K192278 · Uvision360, Inc. · Nov 2019
Omni Hysteroscope, Omni Lok cervical seal
K191281 · Hologic, Inc. · Aug 2019
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
K190827 · Uvision360, Inc. · Jun 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
K191335 · Corinth Medtech, Inc. · Jun 2019