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FDA 510(k)

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

K-Number: K213171 · 2022-05-26

ApplicantMeditrina, Inc.
Decision Date2022-05-26
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) is the device name listed in this FDA 510(k) record. The listed applicant is Meditrina, Inc.. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K213171. 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, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Meditrina, Inc.. The 510(k) number is K213171.

When did Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) receive FDA 510(k) clearance?

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) received FDA 510(k) clearance on 2022-05-26, under 510(k) number K213171.

Who is the listed applicant for Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

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, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

The FDA product code for Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) 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.

K223813Aveta System 2.0K192100Aveta 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

View on FDA Database →

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

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