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FDA 510(k)

Aveta Disposable Hysteroscope

K-Number: K192100 · 2019-12-19

ApplicantMeditrina, Inc.
Decision Date2019-12-19
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Aveta Disposable Hysteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Meditrina, Inc.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K192100. 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 Disposable Hysteroscope?

Aveta Disposable Hysteroscope is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Meditrina, Inc.. The 510(k) number is K192100.

When did Aveta Disposable Hysteroscope receive FDA 510(k) clearance?

Aveta Disposable Hysteroscope received FDA 510(k) clearance on 2019-12-19, under 510(k) number K192100.

Who is the listed applicant for Aveta Disposable Hysteroscope?

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 Disposable Hysteroscope?

The FDA product code for Aveta Disposable Hysteroscope 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 2.0K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)K191958Aveta 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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