Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CIRCON ACMI BICAP III THERAPEUTIC SYSTEM

K-Number: K884254 · 1989-01-11

ApplicantCircon Acmi
Decision Date1989-01-11
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CIRCON ACMI BICAP III THERAPEUTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Circon Acmi. It received FDA 510(k) clearance on 1989-01-11 under 510(k) number K884254. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCON ACMI BICAP III THERAPEUTIC SYSTEM?

CIRCON ACMI BICAP III THERAPEUTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1989-01-11. The listed applicant is Circon Acmi. The 510(k) number is K884254.

When did CIRCON ACMI BICAP III THERAPEUTIC SYSTEM receive FDA 510(k) clearance?

CIRCON ACMI BICAP III THERAPEUTIC SYSTEM received FDA 510(k) clearance on 1989-01-11, under 510(k) number K884254.

Who is the listed applicant for CIRCON ACMI BICAP III THERAPEUTIC SYSTEM?

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

What is the FDA product code for CIRCON ACMI BICAP III THERAPEUTIC SYSTEM?

The FDA product code for CIRCON ACMI BICAP III THERAPEUTIC SYSTEM is KNS.

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 Circon Acmi 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.

K013165USA SERIES LAPAROSCOPESK980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)K905705LAP 3501 HIGH FLOW INSUFFLATORK905706GYN-1500 HYSTEROSCOPIC INUFFLATORK884097MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPESK884025CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200

View all 10 devices →

Related Devices (Code: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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.

↑