FDA.reportPublic FDA data

EndoWrist;daVinci Si

Primary DI
00886874111116
Brand
EndoWrist;daVinci Si
Company
INTUITIVE SURGICAL, INC.
Model
410322
Device description
VESSEL SEALER
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886874111113PackageGS16In Commercial Distribution
00886874111116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088687411111310886874111113
00886874111116008868741111168868741111160886874111116

GMDN Terms#

Term, Definition table
TermDefinition
Robotic endoscopic electrosurgical instrument, bipolar, single-useA electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and may include the distal bipolar electrode in one of a variety of forms (e.g., forceps, hook). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Regulatory Flags#

DUNS number
938647021
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886874121917Sureform48230B2022-05-11
00886874121924Sureform48230W2022-05-11
00886874121931Sureform48230M2022-05-11
00886874124871Ion Tomosynthesis Board3804562025-11-11
00886874112069EndoWrist4280802016-08-03
00886874112106Single-Site; daVinci Si4280932016-08-03
00886874113707Single-Site4780802016-07-08
00886874113738Single-Site4780932016-08-03
00886874115664Endowrist4804222018-05-04
00886874117309da Vinci Energy4804402019-12-10
00886874120736Force Feedback4751722024-03-21
00886874120743Force Feedback4752052024-03-21
00886874123362da Vinci Energy4805222025-08-14
00886874125649Force Feedback4771722026-03-26
00886874125656Force Feedback4772052026-03-26
00886874125571Force Feedback4761722025-01-29
00886874125588Force Feedback4762052025-01-29
00886874123447EndoWrist SP4301512024-12-09
00886874123454EndoWrist SP4301002024-12-09
00886874123461EndoWrist SP4301522024-12-09

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
00886874123188da Vinci SP Endoscope, 0°INTUITIVE SURGICAL, INC.NAY2025-09-04
00886874123362da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
00886874124598NoneINTUITIVE SURGICAL, INC.NAY2025-07-08
00886874123645SureFormINTUITIVE SURGICAL, INC.NAY2025-06-20
00886874123652SureFormINTUITIVE SURGICAL, INC.NAY2025-06-20
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
00886874123447EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874123454EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874123461EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874124048EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874124055EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874124079EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874124147EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874125434Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-07-29
00886874125458Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-07-29
00886874120293NoneINTUITIVE SURGICAL, INC.NAY2024-03-22
00886874120705Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00886874120712Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21