FDA.reportPublic FDA data

Senhance Ultrasonic

Primary DI
00815440021566
Brand
Senhance Ultrasonic
Company
Asensus Surgical, Inc.
Model
X9007619
Catalog number
300-11010
Device description
Senhance Ultrasonic Dissector
Published
2019-02-04
Public version status
Update
Distribution status
Not 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
10815440021563PackageGS110Not in Commercial Distribution
00815440021566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081544002156310815440021563
00815440021566008154400215668154400215660815440021566

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic robotic surgical instrument, single-useA sterile component of an ultrasonic surgical assembly intended to be connected directly to the arm of a robotic surgical system, and convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is typically in the form of an elongated probe with a proximal housing intended to attach to the robotic arm. This is a single-use device.

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
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
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
00815440021573Senhance UltrasonicX9007620300-110112019-02-04
00815440021580Senhance UltrasonicX9007621300-010102019-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.NAY2026-10-16
08809882470220Articulated Basic Gripper GEndoRobotics Co., Ltd.NAY2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.NAY2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.NAY2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.NAY2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.NAY2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.NAY2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.NAY2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.NAY2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.NAY2026-10-16
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
00815440022266SenhanceAsensus Surgical, Inc.NAY2025-01-14
00815440022273SenhanceAsensus Surgical, Inc.NAY2025-01-14
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
00815440021931SenhanceAsensus Surgical, Inc.NAY2020-08-05
00815440022075SenhanceAsensus Surgical, Inc.NAY2020-08-05
00815440022082SenhanceAsensus Surgical, Inc.NAY2020-08-05