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FDA 510(k)

ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER

K-Number: K881220 · 1988-06-14

ApplicantLaboratoire Ccd C/O Washington Regulatory Services
Decision Date1988-06-14
Product CodeHFE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Laboratoire Ccd C/O Washington Regulatory Services. It received FDA 510(k) clearance on 1988-06-14 under 510(k) number K881220. 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, DISPOSABLE ENDOMETRIAL SAMPLER?

ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER is a medical device that received FDA 510(k) clearance on 1988-06-14. The listed applicant is Laboratoire Ccd C/O Washington Regulatory Services. The 510(k) number is K881220.

When did ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER receive FDA 510(k) clearance?

ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER received FDA 510(k) clearance on 1988-06-14, under 510(k) number K881220.

Who is the listed applicant for ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER?

The FDA 510(k) record lists Laboratoire Ccd C/O Washington Regulatory Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER?

The FDA product code for ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER is HFE.

Related Clinical Trials

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.

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Other records listing Laboratoire Ccd C/O Washington Regulatory Services 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.

K890706CYTOBRUSHK884696RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SETK881456PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE

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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