FDA.reportPublic FDA data

CVAC Aspiration System

Primary DI
00860005357710
Brand
CVAC Aspiration System
Company
Calyxo, Inc.
Model
CVC127020-1
Published
2024-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233472000CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.2024-02-02FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005357710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005357710008600053577108600053577100860005357710

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video ureteroscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.

Regulatory Flags#

DUNS number
080269404
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005357703CVAC Aspiration SystemCVAC702020-12-01
00860005357741CVAC Aspiration SystemCVC127020R-12025-09-10
00860005357727CVAC Image ProcessorIMG000020-12024-02-22
20860005357707CVAC Aspiration SystemCVAC702020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.FGB2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.FGB2026-05-05
10810068811107MONARCH™ Urology Irrigation CartridgeAuris Health, Inc.FGB2026-05-04
10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00860005357741CVAC Aspiration SystemCalyxo, Inc.FED2025-09-10
00860005357741CVAC Aspiration SystemCalyxo, Inc.FGB2025-09-10
08881300750107F88SG ENDOSCOPY PTE. LTD.FGB2025-06-30
04055207070420RIWO D-URSRichard Wolf GmbHFGB2025-04-15
04048551428009NAKarl Storz GmbH & Co. KGFGB2025-03-27
00860012876808Air AssistGASTRO CONCEPTS LLCFED2025-03-17
04048551428030n.a,Karl Storz GmbH & Co. KGFGB2024-11-29
03600040995150ReTraceColoplast A/SFED2024-11-20
03600040995181ReTraceColoplast A/SFED2024-11-20
03600040995211ReTraceColoplast A/SFED2024-11-20
03600040995242ReTraceColoplast A/SFED2024-11-20
03600040995273ReTraceColoplast A/SFED2024-11-20
03600040995303ReTraceColoplast A/SFED2024-11-20
03600040995334ReTraceColoplast A/SFED2024-11-20
03600040995365ReTraceColoplast A/SFED2024-11-20
04953170463501BALLOON SHEATH OLYMPUS MEDICAL SYSTEMS CORP.FED2024-03-25
00860005357727CVAC Image ProcessorCalyxo, Inc.FGB2024-02-22
00850023925329WiScope®Otu Medical Inc.FGB2024-01-12
00850023925336WiScope®Otu Medical Inc.FGB2024-01-12