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FDA 510(k)

UTERINE INJECTOR 4.0MM

K-Number: K841682 · 1984-07-03

ApplicantHumi Corp.
Decision Date1984-07-03
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTERINE INJECTOR 4.0MM is the device name listed in this FDA 510(k) record. The listed applicant is Humi Corp.. It received FDA 510(k) clearance on 1984-07-03 under 510(k) number K841682. The device is classified under product code HES. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UTERINE INJECTOR 4.0MM?

UTERINE INJECTOR 4.0MM is a medical device that received FDA 510(k) clearance on 1984-07-03. The listed applicant is Humi Corp.. The 510(k) number is K841682.

When did UTERINE INJECTOR 4.0MM receive FDA 510(k) clearance?

UTERINE INJECTOR 4.0MM received FDA 510(k) clearance on 1984-07-03, under 510(k) number K841682.

Who is the listed applicant for UTERINE INJECTOR 4.0MM?

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

What is the FDA product code for UTERINE INJECTOR 4.0MM?

The FDA product code for UTERINE INJECTOR 4.0MM is HES.

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 Humi Corp. 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.

K841681UTERINE MANIPULATOR 4.5MM

Related Devices (Code: HES)

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.

K000340HYSTALOG HSG CATHETERRocket Medical PlcK903209MAXI-FLOW INSUFFLATOR TUBING SET W/FILTERAdler Instrument Co.K903208MAXI-FLOW INSUFFLATOR TUBING SETAdler Instrument Co.K904473KRONNER MANIPUJECTORUnimar, Inc.K901413CORE DISPOSABLE INSUFFLATION TUBINGCore Dynamics, Inc.K891290SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETERCook Ob/Gyn

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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