Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aveta System 2.0

K-Number: K223813 · 2023-08-21

ApplicantMeditrina, Inc.
Decision Date2023-08-21
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Aveta System 2.0 is a medical device manufactured by Meditrina, Inc.. It received FDA 510(k) clearance on 2023-08-21 under approval number K223813. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aveta System 2.0?

Aveta System 2.0 is a medical device that received FDA 510(k) clearance on 2023-08-21. It is manufactured by Meditrina, Inc.. The 510(k) number is K223813.

When was Aveta System 2.0 approved by the FDA?

Aveta System 2.0 received FDA 510(k) clearance on 2023-08-21, under approval number K223813.

What company makes Aveta System 2.0?

Aveta System 2.0 is manufactured by Meditrina, Inc..

What is the FDA product code for Aveta System 2.0?

The FDA product code for Aveta System 2.0 is HIH.

Other Devices by Meditrina, Inc.

K192100Aveta Disposable Hysteroscope K191958Aveta System K190372Aveta System K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

Related Devices (Code: HIH)

K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑