FDA.reportPublic FDA data

Articulated Basic Gripper G

Primary DI
08809882470220
Brand
Articulated Basic Gripper G
Company
EndoRobotics Co., Ltd.
Model
AB-G-01
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
NAYSystem, Surgical, Computer Controlled Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
NAYSystem, Surgical, Computer Controlled InstrumentGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K244029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K244029000ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.2025-09-24FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809882470220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809882470220088098824702208809882470220

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical forceps, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
695713079
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
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
08809882470213ROBOPERA™ SETER-RS-0022026-10-16
08809882470237Articulated Dual Gripper GAD-G-012026-10-16
08809882470381ROBOPERA™ UnitR-AL-0022026-10-16
08809882470398ROBOPERA™R-A-0022026-10-16
08809882470404Controller AR-JA-0022026-10-16
08809882470428Controller BR-JB-0022026-10-16
08809882470442ROBOPERA™ AccessoriesR-AC-0012026-10-16
08809882470466R-Power CablePC-R-0022026-10-16
08809882470725ROBOPERA™ Storage CaseRPSC-0012026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDS2026-10-16
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDF2026-10-16
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.NAY2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.NAY2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDS2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDF2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDS2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.NAY2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.NAY2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDS2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDF2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.NAY2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDS2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDF2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.NAY2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDF2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDS2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.NAY2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDS2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDF2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.NAY2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDS2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDF2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.NAY2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDS2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDF2026-10-16
04260463844269ARTip soloAktormed GmbHNAY2026-09-04
04260463844290SET ARTip solo voiceAktormed GmbHNAY2026-09-04
04260463844450ARTip solo voiceAktormed GmbHNAY2026-09-04