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)

ULTRASONIC HAND INSTRUMENTS

K-Number: K971861 · 1997-07-01

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1997-07-01
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC HAND INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1997-07-01 under 510(k) number K971861. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC HAND INSTRUMENTS?

ULTRASONIC HAND INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1997-07-01. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K971861.

When did ULTRASONIC HAND INSTRUMENTS receive FDA 510(k) clearance?

ULTRASONIC HAND INSTRUMENTS received FDA 510(k) clearance on 1997-07-01, under 510(k) number K971861.

Who is the listed applicant for ULTRASONIC HAND INSTRUMENTS?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC HAND INSTRUMENTS?

The FDA product code for ULTRASONIC HAND INSTRUMENTS 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 United States Surgical, A Division of Tyco Healthc 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.

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERK071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORK061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERK062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSK062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEK061095AUTO SUTUR ENDO GIA STAPLERS

View all 218 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.

↑