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)

MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)

K-Number: K970471 · 1997-07-17

ApplicantMentor Corp.
Decision Date1997-07-17
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1997-07-17 under 510(k) number K970471. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)?

MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) is a medical device that received FDA 510(k) clearance on 1997-07-17. The listed applicant is Mentor Corp.. The 510(k) number is K970471.

When did MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) receive FDA 510(k) clearance?

MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) received FDA 510(k) clearance on 1997-07-17, under 510(k) number K970471.

Who is the listed applicant for MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)?

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

What is the FDA product code for MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)?

The FDA product code for MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) is LFL.

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 Mentor 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

View all 61 devices →

Related Devices (Code: LFL)

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.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences 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.

↑