FDA.reportPublic FDA data

Senhance

Primary DI
00815440020149
Brand
Senhance
Company
Asensus Surgical, Inc.
Model
X0007023
Catalog number
200-11048
Device description
Needle Holder Left
Published
2017-11-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K171120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171120000Senhance Surgical Robotic SystemTransenterix, Inc.2017-10-13NAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815440020149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815440020149008154400201498154400201490815440020149

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical forceps, reusableA surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
969118900
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815440022624SenhanceX00171772026-03-09
00815440022266SenhanceX90077702025-01-14
00815440022273SenhanceX90077712025-01-14
00815440021924SenhanceX90076802023-09-19
00815440021825SenhanceX90076722023-08-17
00815440021856SenhanceX90076752023-08-17
00815440022235SenhanceX90077552023-08-17
00815440022242SenhanceX90077582023-08-17
00815440022259SenhanceX90077592023-08-17
00815440022280SenhanceX9007775X90077752022-07-11
00815440022228SenhanceX9007741X90077412021-02-19
00815440021931SenhanceX90076962020-08-05
00815440022075SenhanceX90077082020-08-05
00815440022082SenhanceX90077072020-08-05
00815440021122Senhance UltrasonicX9007618300-210112019-02-04
00815440021405SenhanceX9007034210-210112019-08-01
00815440021443SenhanceX9007306220-210122019-02-04
00815440021450SenhanceX9007309220-210102019-02-04
00815440021566Senhance UltrasonicX9007619300-110102019-02-04
00815440021573Senhance UltrasonicX9007620300-110112019-02-04

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
00886874123447EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
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