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FDA 510(k)

MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4

K-Number: K853216 · 1986-04-02

ApplicantGyneco, Inc.
Decision Date1986-04-02
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 is the device name listed in this FDA 510(k) record. The listed applicant is Gyneco, Inc.. It received FDA 510(k) clearance on 1986-04-02 under 510(k) number K853216. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4?

MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 is a medical device that received FDA 510(k) clearance on 1986-04-02. The listed applicant is Gyneco, Inc.. The 510(k) number is K853216.

When did MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 receive FDA 510(k) clearance?

MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 received FDA 510(k) clearance on 1986-04-02, under 510(k) number K853216.

Who is the listed applicant for MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4?

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

What is the FDA product code for MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4?

The FDA product code for MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 is HHK.

Related Clinical Trials

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Other records listing Gyneco, 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.

K861409SYNCARE TEMPORARY CARDIAC PACING WIREK852357GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIPK843941ENDOCYTEK841275FINE NEEDLE ASPIRATION DEVICE

Related Devices (Code: HHK)

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.

K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay MedicalK192534CrossBay Endometrial Tissue Sampler (ETS)Crossbay MedicalK102847DISPOSABLE ENDOMETRIAL SUCTION CURETTEJiangsu Suyun Medical Materials Co., Ltd.K092982THE PANPAC SUCTION CURETTEPanpac Medical Corporation

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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