FDA.reportPublic FDA data

None

Primary DI
10886874124588
Brand
None
Company
INTUITIVE SURGICAL, INC.
Model
432701
Device description
None
Published
2025-07-08
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243582000da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.2025-02-28NAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886874124588PackageGS16In Commercial Distribution
00886874124598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088687412458810886874124588
00886874124598008868741245988868741245980886874124598

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic multi-instrument access port, single-useA sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
938647021
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00886874111116EndoWrist;daVinci Si4103222016-08-03
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

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