FDA.reportPublic FDA data

Veloxion

Primary DI
00860011104445
Brand
Veloxion
Company
Aulea Medical Inc.
Model
2516
Catalog number
2516
Device description
Veloxion Controller Kit
Published
2025-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJLResectoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJLResectoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230205000Veloxion SystemCorinth Medtech, Inc.2023-02-24FJL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011104445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011104445008600111044458600111044450860011104445

GMDN Terms#

Term, Definition table
TermDefinition
ResectoscopeAn endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9255330018qa@auleamed.com

Regulatory Flags#

DUNS number
119365804
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011104438Veloxion187818782025-01-03
00860011104407Veloxion249024902025-01-03
00860011104414Veloxion132713272025-01-03
00860011104421Veloxion187718772025-01-03
00860011104483Veloxion187818782025-01-03
00860011104452Veloxion319931992025-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207048788NARichard Wolf GmbHFJL2026-05-13
04055207071717PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071731PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071724PIRANHARichard Wolf GmbHFJL2025-11-17
04055207071748PIRANHARichard Wolf GmbHFJL2025-11-17
00848657077507AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2025-08-25
04048551411704NAKarl Storz GmbH & Co. KGFJL2025-03-27
00860011104438VeloxionAulea Medical Inc.FJL2025-01-03
00860011104407VeloxionAulea Medical Inc.FJL2025-01-03
00860011104414VeloxionAulea Medical Inc.FJL2025-01-03
00860011104421VeloxionAulea Medical Inc.FJL2025-01-03
00860011104483VeloxionAulea Medical Inc.FJL2025-01-03
00860011104452VeloxionAulea Medical Inc.FJL2025-01-03
04048438005408n.a.Karl Storz GmbH & Co. KGFJL2024-10-04
04055207007822NARichard Wolf GmbHFJL2024-08-19
04055207008393NARichard Wolf GmbHFJL2024-08-19
04055207058985NARichard Wolf GmbHFJL2024-08-19
04055207069936NARichard Wolf GmbHFJL2024-08-19
04055207011911NARichard Wolf GmbHFJL2024-08-19
04055207038673NARichard Wolf GmbHFJL2024-04-01
04055207069783NARichard Wolf GmbHFJL2024-04-01
04055207057322SHARKRichard Wolf GmbHFJL2024-03-29
04055207055106PANOVIEWRichard Wolf GmbHFJL2023-08-03
04055207055113PANOVIEWRichard Wolf GmbHFJL2023-08-03
14042761085493OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085530OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085547OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085554OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085561OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085578OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27