FDA.reportPublic FDA data

None

Primary DI
10886874111014
Brand
None
Company
INTUITIVE SURGICAL, INC.
Model
400156
Device description
CAUTERY HOOK TIP
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10886874111014PackageGS110In Commercial Distribution
30886874111018PackageGS11In Commercial Distribution
00886874111017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088687411101410886874111014
3088687411101830886874111018
00886874111017008868741110178868741110170886874111017

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

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
00886874110720daVinci Xi3806522016-07-08
00886874110744daVinci Xi3806772016-07-08
00886874110898daVinci Xi3811212016-07-08
00886874112298EndoWrist4701792016-07-08
00886874112342EndoWrist4701942016-07-08
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
00886874116234Ion3807482019-03-21
00886874125663Force Feedback4773092026-03-26
00886874116241Ion3807072019-03-21
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