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FDA 510(k)

IUMC ENDOMETRIAL SAMPLER

K-Number: K941298 · 1995-02-13

ApplicantCook Ob/Gyn
Decision Date1995-02-13
Product CodeHFE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IUMC ENDOMETRIAL SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1995-02-13 under 510(k) number K941298. 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 IUMC ENDOMETRIAL SAMPLER?

IUMC ENDOMETRIAL SAMPLER is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is Cook Ob/Gyn. The 510(k) number is K941298.

When did IUMC ENDOMETRIAL SAMPLER receive FDA 510(k) clearance?

IUMC ENDOMETRIAL SAMPLER received FDA 510(k) clearance on 1995-02-13, under 510(k) number K941298.

Who is the listed applicant for IUMC ENDOMETRIAL SAMPLER?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IUMC ENDOMETRIAL SAMPLER?

The FDA product code for IUMC ENDOMETRIAL SAMPLER is HFE.

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Other records listing Cook Ob/Gyn 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.

K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500K030441SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KITK023850SYDNEY IVF EMBRYO BIOPSY MEDIUMK013597TAMPONADE UTERINE BALLOON CATHETER SETK002385COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,K002383COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT

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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.K911620STOVALL ENDOMETRIAL BRUSHCook Ob/GynK897070ENDOBRUSH(TM) DEVICE; OMNIBRUSHIntl. Cytobrush, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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