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FDA 510(k)

TEFLON UTERINE SOUND

K-Number: K870550 · 1987-03-04

ApplicantCook Ob/Gyn
Decision Date1987-03-04
Product CodeHHM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TEFLON UTERINE SOUND 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 1987-03-04 under 510(k) number K870550. The device is classified under product code HHM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEFLON UTERINE SOUND?

TEFLON UTERINE SOUND is a medical device that received FDA 510(k) clearance on 1987-03-04. The listed applicant is Cook Ob/Gyn. The 510(k) number is K870550.

When did TEFLON UTERINE SOUND receive FDA 510(k) clearance?

TEFLON UTERINE SOUND received FDA 510(k) clearance on 1987-03-04, under 510(k) number K870550.

Who is the listed applicant for TEFLON UTERINE SOUND?

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 TEFLON UTERINE SOUND?

The FDA product code for TEFLON UTERINE SOUND is HHM.

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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: HHM)

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.

K011840CERVILENZ UTERINE MEASURING SOUNDCervilenz, Inc.K935665INTRAUTERINE SOUNDRocket of London, Ltd.K884684ROCKET INTRAUTERINE DEPTH SOUNDA & A Medical, Inc.K883806ROCKET INTRAUTERINE SOUNDA & A Medical, Inc.K840380UTERINE SOUNDIntl. Medical Technologies, Inc.K831224AUGROS HYSTEROMETERAxcan Scientific Corp.

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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