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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 the device name listed in this FDA 510(k) record. The listed applicant is Meditrina, Inc.. It received FDA 510(k) clearance on 2023-08-21 under 510(k) 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. The listed applicant is Meditrina, Inc.. The 510(k) number is K223813.

When did Aveta System 2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Aveta System 2.0?

The FDA 510(k) record lists Meditrina, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aveta System 2.0?

The FDA product code for Aveta System 2.0 is HIH.

Other records listing Meditrina, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)K192100Aveta Disposable HysteroscopeK191958Aveta SystemK190372Aveta System

Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

Official Source

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

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