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FDA 510(k)

HR-5000 ELECTROSURGICAL DEVICE

K-Number: K864869 · 1987-05-19

ApplicantIme Co. , Ltd.
Decision Date1987-05-19
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HR-5000 ELECTROSURGICAL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ime Co. , Ltd.. It received FDA 510(k) clearance on 1987-05-19 under 510(k) number K864869. The device is classified under product code KCW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HR-5000 ELECTROSURGICAL DEVICE?

HR-5000 ELECTROSURGICAL DEVICE is a medical device that received FDA 510(k) clearance on 1987-05-19. The listed applicant is Ime Co. , Ltd.. The 510(k) number is K864869.

When did HR-5000 ELECTROSURGICAL DEVICE receive FDA 510(k) clearance?

HR-5000 ELECTROSURGICAL DEVICE received FDA 510(k) clearance on 1987-05-19, under 510(k) number K864869.

Who is the listed applicant for HR-5000 ELECTROSURGICAL DEVICE?

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

What is the FDA product code for HR-5000 ELECTROSURGICAL DEVICE?

The FDA product code for HR-5000 ELECTROSURGICAL DEVICE is KCW.

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 Ime Co. , Ltd. 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.

K881276HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS

Related Devices (Code: KCW)

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.

K954031COMPU-BLEND EPILATORR. A. Fischer Co. Corp.K952611STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATIONSterex Electrolysis Intl., Ltd.K945192HAIR REMOVAL SYSTEML.P. Systems Corp.K943928APILUS ELECTROPILDectro Intl., Inc.K943399THE SS-99InstantronK943396THE ELITE SPECTRUMInstantron

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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