FDA 510(k)

OUTPATIENT III MINOR SURGERY LIGHT

K-Number: K042395 · 2004-12-01

Decision Date2004-12-01

Product CodeFSY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OUTPATIENT III MINOR SURGERY LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Burton Medical Products Corp.. It received FDA 510(k) clearance on 2004-12-01 under 510(k) number K042395. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OUTPATIENT III MINOR SURGERY LIGHT?

OUTPATIENT III MINOR SURGERY LIGHT is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Burton Medical Products Corp.. The 510(k) number is K042395.

When did OUTPATIENT III MINOR SURGERY LIGHT receive FDA 510(k) clearance?

OUTPATIENT III MINOR SURGERY LIGHT received FDA 510(k) clearance on 2004-12-01, under 510(k) number K042395.

Who is the listed applicant for OUTPATIENT III MINOR SURGERY LIGHT?

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

What is the FDA product code for OUTPATIENT III MINOR SURGERY LIGHT?

The FDA product code for OUTPATIENT III MINOR SURGERY LIGHT is FSY.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Burton Medical Products Corp. as applicant

K101537AIM 200, MAJOR SURGICAL LIGHT K000639VISIONARY 2000 K963682GENIE' SINGLE CEILING AND DOUBLE CEILING K961843GENIE K935102SATURN LIGHT K942553GENESIS

View all 15 devices →

Related Devices (Code: FSY)

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker Communications K132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems Corporation K131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KG K102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

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.