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FDA 510(k)

UTERINE SOUND

K-Number: K802315 · 1981-01-12

ApplicantGynemetrics, Inc.
Decision Date1981-01-12
Product CodeHHM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTERINE SOUND is the device name listed in this FDA 510(k) record. The listed applicant is Gynemetrics, Inc.. It received FDA 510(k) clearance on 1981-01-12 under 510(k) number K802315. 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 UTERINE SOUND?

UTERINE SOUND is a medical device that received FDA 510(k) clearance on 1981-01-12. The listed applicant is Gynemetrics, Inc.. The 510(k) number is K802315.

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

UTERINE SOUND received FDA 510(k) clearance on 1981-01-12, under 510(k) number K802315.

Who is the listed applicant for UTERINE SOUND?

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

What is the FDA product code for UTERINE SOUND?

The FDA product code for UTERINE SOUND is HHM.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gynemetrics, 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.

K811568CERVICAL DILATORK803210MENSTRUAL ASPIRATION KITSK802313UTERINE CURETTE

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.K870550TEFLON UTERINE SOUNDCook Ob/GynK840380UTERINE SOUNDIntl. Medical Technologies, 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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