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FDA 510(k)

GDT-1000 System

K-Number: K180096 · 2018-04-16

ApplicantAcuvu, Inc.
Decision Date2018-04-16
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GDT-1000 System is the device name listed in this FDA 510(k) record. The listed applicant is Acuvu, Inc.. It received FDA 510(k) clearance on 2018-04-16 under 510(k) number K180096. 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 GDT-1000 System?

GDT-1000 System is a medical device that received FDA 510(k) clearance on 2018-04-16. The listed applicant is Acuvu, Inc.. The 510(k) number is K180096.

When did GDT-1000 System receive FDA 510(k) clearance?

GDT-1000 System received FDA 510(k) clearance on 2018-04-16, under 510(k) number K180096.

Who is the listed applicant for GDT-1000 System?

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

What is the FDA product code for GDT-1000 System?

The FDA product code for GDT-1000 System is HIH.

Other records listing Acuvu, 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.

K211227HTx Disposable Hysteroscope 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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