FDA.reportPublic FDA data

None

Primary DI
00886874122105
Brand
None
Company
INTUITIVE SURGICAL, INC.
Model
470062
Device description
8MM HEX CANNULA, STANDARD
Published
2024-03-23
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
K232610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232610000da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke EvacuationIntuitive Surgical, Inc.2024-03-14NAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886874122105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886874122105008868741221058868741221050886874122105

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
938647021
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886874112342EndoWrist4701942016-07-08
00886874116234Ion3807482019-03-21
00886874116241Ion3807072019-03-21
00886874110898daVinci Xi3811212016-07-08
00886874110720daVinci Xi3806522016-07-08
00886874110744daVinci Xi3806772016-07-08
00886874112298EndoWrist4701792016-07-08
00886874115374da Vinci Xi3807232017-11-01
00886874115404daVinci X3806202017-06-06
00886874112366EndoWrist4702072016-07-08
00886874112120EndoWrist4700012016-07-08
00886874112168EndoWrist4700072016-07-08
00886874112229EndoWrist4700332016-07-08
00886874112236EndoWrist4700362016-07-08
00886874112304EndoWrist4701812016-07-08
00886874125663Force Feedback4773092026-03-26
00886874115732None4700422019-08-26
00886874112786None9510212016-07-08
00886874112793None9510262016-07-08
00886874115602None3130352017-07-12

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