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)

VELOPEX AQUACUT FLUID ABRASION UNIT

K-Number: K024105 · 2003-10-09

ApplicantVelopex International, Inc.
Decision Date2003-10-09
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VELOPEX AQUACUT FLUID ABRASION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Velopex International, Inc.. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K024105. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELOPEX AQUACUT FLUID ABRASION UNIT?

VELOPEX AQUACUT FLUID ABRASION UNIT is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Velopex International, Inc.. The 510(k) number is K024105.

When did VELOPEX AQUACUT FLUID ABRASION UNIT receive FDA 510(k) clearance?

VELOPEX AQUACUT FLUID ABRASION UNIT received FDA 510(k) clearance on 2003-10-09, under 510(k) number K024105.

Who is the listed applicant for VELOPEX AQUACUT FLUID ABRASION UNIT?

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

What is the FDA product code for VELOPEX AQUACUT FLUID ABRASION UNIT?

The FDA product code for VELOPEX AQUACUT FLUID ABRASION UNIT is KOJ.

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 Velopex International, 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.

K111167XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINTK093503INTRAX FILM PROCESSOR

Related Devices (Code: KOJ)

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.

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase CorporationK042872RONDOFLEX PLUS 360Kavo America CorporationK033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbHK033215PREPAIRDanville Materials, Inc.K030292GROMAN PREPMASTERGroman, 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.

↑