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FDA 510(k)

ENDOCYTE

K-Number: K843941 · 1985-02-25

ApplicantGyneco, Inc.
Decision Date1985-02-25
Product CodeHFE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOCYTE is the device name listed in this FDA 510(k) record. The listed applicant is Gyneco, Inc.. It received FDA 510(k) clearance on 1985-02-25 under 510(k) number K843941. The device is classified under product code HFE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOCYTE?

ENDOCYTE is a medical device that received FDA 510(k) clearance on 1985-02-25. The listed applicant is Gyneco, Inc.. The 510(k) number is K843941.

When did ENDOCYTE receive FDA 510(k) clearance?

ENDOCYTE received FDA 510(k) clearance on 1985-02-25, under 510(k) number K843941.

Who is the listed applicant for ENDOCYTE?

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 ENDOCYTE?

The FDA product code for ENDOCYTE is HFE.

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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 WIREK853216MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4K852357GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIPK841275FINE NEEDLE ASPIRATION DEVICE

Related Devices (Code: HFE)

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.

K240595Utepreva Endometrial Sampler (UP01)Utepreva, LLCK170603Tao Brush I.U.M.C. Endometrial SamplerCook IncorporatedK112763MATRIXBRUSH ENDOMETRIAL SAMPLERPost Oak Innovations, Inc.K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERCook Urological, Inc.K941298IUMC ENDOMETRIAL SAMPLERCook Ob/GynK911620STOVALL ENDOMETRIAL BRUSHCook Ob/Gyn

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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