FDA.reportPublic FDA data

Cyber Blade

Primary DI
08059173391707
Brand
Cyber Blade
Company
QUANTA SYSTEM SPA
Model
CVA000002
Device description
Cyber Blade Morcelletor Set
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
08059173391707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059173391707080591733917078059173391707

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
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28