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)

MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM

K-Number: K042096 · 2006-01-26

ApplicantMisonix, Inc.
Decision Date2006-01-26
Product CodeNTB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Misonix, Inc.. It received FDA 510(k) clearance on 2006-01-26 under 510(k) number K042096. The device is classified under product code NTB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM?

MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-26. The listed applicant is Misonix, Inc.. The 510(k) number is K042096.

When did MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM receive FDA 510(k) clearance?

MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM received FDA 510(k) clearance on 2006-01-26, under 510(k) number K042096.

Who is the listed applicant for MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM?

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

What is the FDA product code for MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM?

The FDA product code for MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM is NTB.

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 Misonix, 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.

K221235neXus Ultrasonic Surgical Aspirator SystemK212060neXus Ultrasonic Surgical Aspirator SystemK190160neXus Ultrasonic Surgical Aspirator SystemK123980SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIESK112782MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIESK070779SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM

View all 17 devices →

Related Devices (Code: NTB)

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.

K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.K070779SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEMMisonix, Inc.K060346ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEMUltrazonix Dnt ABK040641ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1Epicor Medical, Inc.K022894EPICOR MEDICAL ABLATION SYSTEMEpicor Medical, 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.

↑