FDA.reportPublic FDA data

EndoWrist;daVinci Si

Primary DI
00886874111147
Brand
EndoWrist;daVinci Si
Company
INTUITIVE SURGICAL, INC.
Model
420001
Device description
POTTS SCISSORS
Published
2016-07-08
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
K050369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050369000INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000Intuitive Surgical, Inc.2005-04-29NAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886874111147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886874111147008868741111478868741111470886874111147

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical scissorsA surgical device intended to be used in conjunction with a robotic surgical system to cut tissue or sutures during a robotic endoscopic procedure. It is designed as a long shaft with a pair of mechanical (i.e., not electrosurgical) cutting blades at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
938647021
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886874114343None4300122018-09-20
00886874113509EntryGuide4300222018-09-20
00886874114353None4300202018-09-20
00886874114377None4300352018-09-20
00886874119549None4300732021-03-11
00886874119556None4300752021-03-11
00886874121726Sureform4885302022-05-11
00886874121917Sureform48230B2022-05-11
00886874121924Sureform48230W2022-05-11
00886874121931Sureform48230M2022-05-11
00886874123645SureForm4365022025-06-20
00886874123652SureForm4365042025-06-20
00886874124598None4327012025-07-08
00886874125618Force Feedback4770062026-03-26
00886874125625Force Feedback4770492026-03-26
00886874125632Force Feedback4770932026-03-26
00886874125649Force Feedback4771722026-03-26
00886874125656Force Feedback4772052026-03-26
00886874125663Force Feedback4773092026-03-26
00886874125557Force Feedback4760062025-01-29

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
00815440022266SenhanceAsensus Surgical, Inc.NAY2025-01-14