FDA.reportPublic FDA data

Senhance

Primary DI
00815440022266
Brand
Senhance
Company
Asensus Surgical, Inc.
Model
X9007770
Device description
KARL STORZ 4K 5 mm Endoscope Adapter
Published
2025-01-14
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
K171120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171120000Senhance Surgical Robotic SystemTransenterix, Inc.2017-10-13NAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815440022266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815440022266008154400222668154400222660815440022266

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical arm systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
969118900
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815440022273SenhanceX90077712025-01-14
00815440021924SenhanceX90076802023-09-19
00815440021825SenhanceX90076722023-08-17
00815440021856SenhanceX90076752023-08-17
00815440022235SenhanceX90077552023-08-17
00815440022242SenhanceX90077582023-08-17
00815440022259SenhanceX90077592023-08-17
00815440022280SenhanceX9007775X90077752022-07-11
00815440021931Senhance X9007696 2020-08-05
00815440022075SenhanceX90077082020-08-05
00815440022082Senhance X90077072020-08-05
00815440021122Senhance UltrasonicX9007618300-210112019-02-04
00815440021405SenhanceX9007034210-210112019-08-01
00815440021443SenhanceX9007306220-210122019-02-04
00815440021450SenhanceX9007309220-210102019-02-04
00815440021740SenhanceX9007649500-210172019-02-04
00815440021757SenhanceX9007660500-210162019-02-04
00815440021764SenhanceX9007661500-210152019-02-04
00815440021016SenhanceX9007221210-210142019-11-27
00815440020286SenhanceX9007626100-010172017-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886874125618Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125625Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125632Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125649Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125656Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00886874125663Force FeedbackINTUITIVE SURGICAL, INC.NAY2026-03-26
00815440022624SenhanceAsensus Surgical, Inc.NAY2026-03-09
00886874125946NoneINTUITIVE SURGICAL, INC.NAY2025-09-23
00886874125960NoneINTUITIVE SURGICAL, INC.NAY2025-09-23
10886874125974NoneINTUITIVE SURGICAL, INC.NAY2025-09-23
10886874125998NoneINTUITIVE SURGICAL, INC.NAY2025-09-23
00886874123188da Vinci SP Endoscope, 0°INTUITIVE SURGICAL, INC.NAY2025-09-04
00886874123362da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
10886874123369da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
00886874124598NoneINTUITIVE SURGICAL, INC.NAY2025-07-08
10886874124588NoneINTUITIVE SURGICAL, INC.NAY2025-07-08
00886874123645SureFormINTUITIVE SURGICAL, INC.NAY2025-06-20
00886874123652SureFormINTUITIVE SURGICAL, INC.NAY2025-06-20
10886874123659SureFormINTUITIVE SURGICAL, INC.NAY2025-06-20
00886874125854NoneINTUITIVE SURGICAL, INC.NAY2025-04-16
00886874125915NoneINTUITIVE SURGICAL, INC.NAY2025-04-16
00886874125922NoneINTUITIVE SURGICAL, INC.NAY2025-04-16
00886874125939NoneINTUITIVE SURGICAL, INC.NAY2025-04-16
00886874125557Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125564Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125571Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125595Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125601Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00886874125588Force FeedbackINTUITIVE SURGICAL, INC.NAY2025-01-29
00815440022273SenhanceAsensus Surgical, Inc.NAY2025-01-14