FDA.reportPublic FDA data

SOLOASSIST II Set

Primary DI
04260463849103
Brand
SOLOASSIST II Set
Company
Aktormed GmbH
Model
171910
Device description
Set consisting of- 1x Power supply with power cord US (172035 + 172054)- 1x Supply cable (172054)- 1x SOLOASSIST II (141364)- 1x Trolley (120874)- 1x Operating Instruction
Published
2019-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NAYSystem, Surgical, Computer Controlled Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAYSystem, Surgical, Computer Controlled InstrumentGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171947000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171947000SOLOASSIST IIAktormed GmbH2018-09-21NAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260463849103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260463849103042604638491034260463849103

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
537223815
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260463842357Sterile Set1822352026-09-04
04260463844269ARTip solo2024262026-09-04
04260463844290SET ARTip solo voice2024292026-09-04
04260463844450ARTip solo voice2024452026-09-04
04260463845334BUNDLE JOYSTICK-LH-US2125332026-09-04
04260463845341BUNDLE JOYSTICK-RH-US2125342026-09-04
14260463842064Power Cord C13182206 (US)2026-09-04
04260463842333ENDOSCOPE CLAMP A1822332026-02-25
04260463845273STERILISATION TRAY1415272026-02-25
04260463846867ENDOSCOPE CLAMP B1516862026-02-25
04260463849066CONTROL1719062026-02-25
04260463849127ENDOFIX EXO SET1719122026-02-25
04260463849271CONE ADAPTER1719272026-02-25
04260463849431Endofix EXO1719432025-07-30
04260463845181PROBE PIN2125182125182024-10-02
04260463842821STERILISATION TRAY XL1922821922822024-10-01
04260463844801CANTILEVER2124802124802024-10-01
04260463844825JOINT2124822124822024-10-01
04260463844993Dexter Endoscope Arm2124992124992024-10-01
04260463845907ENDOSCOPE CLAMP2225902225902024-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260463844269ARTip soloAktormed GmbHNAY2026-09-04
04260463844290SET ARTip solo voiceAktormed GmbHNAY2026-09-04
04260463844450ARTip solo voiceAktormed GmbHNAY2026-09-04
14260463842064Power Cord C13Aktormed GmbHNAY2026-09-04
00815440022624SenhanceAsensus Surgical, Inc.NAY2026-03-09
00886874123362da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
00815440022266SenhanceAsensus Surgical, Inc.NAY2025-01-14
00815440022273SenhanceAsensus Surgical, Inc.NAY2025-01-14
00886874120736Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00886874120743Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00815440021924SenhanceAsensus Surgical, Inc.NAY2023-09-19
00815440021825SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440021856SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022235SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022242SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022259SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022280SenhanceAsensus Surgical, Inc.NAY2022-07-11
00886874121917SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121924SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121931SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121474EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00886874121511EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00886874121528EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00815440021931SenhanceAsensus Surgical, Inc.NAY2020-08-05
00815440022075SenhanceAsensus Surgical, Inc.NAY2020-08-05
00815440022082SenhanceAsensus Surgical, Inc.NAY2020-08-05
00886874119792EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874119808EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874120767EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874119136EndoWrist;daVinci SiINTUITIVE SURGICAL, INC.NAY2020-02-19