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)

SONOSURG TROCAR

K-Number: K042160 · 2005-01-25

ApplicantAomori Olympus Co., Ltd.
Decision Date2005-01-25
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

SONOSURG TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Aomori Olympus Co., Ltd.. It received FDA 510(k) clearance on 2005-01-25 under 510(k) number K042160. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOSURG TROCAR?

SONOSURG TROCAR is a medical device that received FDA 510(k) clearance on 2005-01-25. The listed applicant is Aomori Olympus Co., Ltd.. The 510(k) number is K042160.

When did SONOSURG TROCAR receive FDA 510(k) clearance?

SONOSURG TROCAR received FDA 510(k) clearance on 2005-01-25, under 510(k) number K042160.

Who is the listed applicant for SONOSURG TROCAR?

The FDA 510(k) record lists Aomori Olympus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOSURG TROCAR?

The FDA product code for SONOSURG TROCAR 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 Aomori Olympus Co., Ltd. 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.

K041566SONOSURG ULTRASONIC SURGICAL SYSTEMK033333SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-BK031523OLYMPUS ULTRASONIC SURGICAL SYSTEMK031710OLYMPUS ULTRASONIC SURGICAL SYSTEMK021672PANCREATIC DRAINAGE TUBEK022446MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C

View all 7 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.

↑