FDA.reportPublic FDA data

Cyber Blade

Primary DI
08059173391691
Brand
Cyber Blade
Company
QUANTA SYSTEM SPA
Model
CVA000001
Device description
Cyber Blade Starting Kit
Published
2021-02-04
Public version status
Update
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192499000Cyber BladeSIDAM S.r.l.2020-07-31GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059173391691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059173391691080591733916918059173391691

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation system handpiece, battery-poweredA battery-powered, hand-held device intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery (e.g., prostate tissue morcellation during laparoscopy). It consists of a cordless instrument with a high-speed rotating blade in a holder. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436045833
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059173396573Single Use CO2 Laser fiberHAF8050012026-01-26
08059173396580Single Use CO2 Laser fiberHAF8050012026-01-26
08059173396535Levanta PlusPCMS003562025-11-27
08059173396474Karma PCMS003552023-12-13
08059173394494Youlaser PRIME MTPYMS000112025-11-05
08059173394500Youlaser PRIMEPYMS000122025-11-05
08059173394517Youlaser PRIME CO2PGMS000172025-11-05
08059173396481Optiscan PRIME OAM0018862025-11-05
08059173392186Litho EVOPVMS000642025-09-29
08059173390960Litho EVOPVMS000582020-01-27
08059173393046Suprema VTPCMS005012023-02-13
08059173393053Duetto SupremaPCMS005022023-02-13
08059173393107Domino SupremaPCMS005072023-02-13
08059173392230Accure PFMS000042022-12-01
08033945936969Thunder PCMS004052017-08-04
08033945936976Thunder VTPCMS004062017-08-04
08033945936983 Thunder HRPCMS004072017-08-04
08033945937638585PDMS005802017-11-06
08033945938857DenaVePDMS002532018-06-08
08033945931490Quanta 1470PDMS001862016-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18