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)

BOVIE ULTRASONIC SURGICAL SYSTEM

K-Number: K855138 · 1986-11-10

ApplicantClinical Technology Corp.
Decision Date1986-11-10
Product CodeLBK
DecisionSubstantially Equivalent

Device Summary

BOVIE ULTRASONIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Technology Corp.. It received FDA 510(k) clearance on 1986-11-10 under 510(k) number K855138. The device is classified under product code LBK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOVIE ULTRASONIC SURGICAL SYSTEM?

BOVIE ULTRASONIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1986-11-10. The listed applicant is Clinical Technology Corp.. The 510(k) number is K855138.

When did BOVIE ULTRASONIC SURGICAL SYSTEM receive FDA 510(k) clearance?

BOVIE ULTRASONIC SURGICAL SYSTEM received FDA 510(k) clearance on 1986-11-10, under 510(k) number K855138.

Who is the listed applicant for BOVIE ULTRASONIC SURGICAL SYSTEM?

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

What is the FDA product code for BOVIE ULTRASONIC SURGICAL SYSTEM?

The FDA product code for BOVIE ULTRASONIC SURGICAL SYSTEM is LBK.

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 Clinical Technology 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.

K925080TEK-LUBEK872867BIOSIGNK880166BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000K872705BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)K854231ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCESK853507STERI-GRIP

View all 12 devices →

Related Devices (Code: LBK)

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.

K972612DISSECTRON PORTABLE UNITSatelecK962952OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)Olympus Optical, Co.K884412CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.Valleylab, Inc.K884413CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATORValleylab, Inc.K883522AMERIMED ULTRASONIC SURGICAL ASPIRATION KITAmerimed US Corp.K853143COOPER LASER SONICS CUSA MODEL 200Cooper Lasersonics, 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.

↑