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FDA 510(k)

ACUSYST-P/3X

K-Number: K875151 · 1988-01-12

ApplicantEndotronics, Inc.
Decision Date1988-01-12
Product CodeKJH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACUSYST-P/3X is the device name listed in this FDA 510(k) record. The listed applicant is Endotronics, Inc.. It received FDA 510(k) clearance on 1988-01-12 under 510(k) number K875151. The device is classified under product code KJH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSYST-P/3X?

ACUSYST-P/3X is a medical device that received FDA 510(k) clearance on 1988-01-12. The listed applicant is Endotronics, Inc.. The 510(k) number is K875151.

When did ACUSYST-P/3X receive FDA 510(k) clearance?

ACUSYST-P/3X received FDA 510(k) clearance on 1988-01-12, under 510(k) number K875151.

Who is the listed applicant for ACUSYST-P/3X?

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

What is the FDA product code for ACUSYST-P/3X?

The FDA product code for ACUSYST-P/3X is KJH.

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 Endotronics, 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.

K872086ACUSYST-JRK864334ACUSYST-P (CELL CULTURE EQUIPMENT)

Related Devices (Code: KJH)

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.

K872086ACUSYST-JREndotronics, Inc.K864334ACUSYST-P (CELL CULTURE EQUIPMENT)Endotronics, Inc.

Official Source

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

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