PROBE ARM SET B - MAJ-1153
Device Description
A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PGU
Device Name: Spatial Imaging For Display Of Endoscope Position
Device Class: 2
Physical State: A control unit that communicates with an endoscope/accessory probe, a receiver dish, and display monitor.
Definition: To detect and display the shape of an inserted endoscope.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Measures electromagnetic fields from the endoscope or an accessory within an endoscope to determine the shape of an inserted endoscope, and displays it on a monitor.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Gastrointestinal system
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Code: FDA
Device Name: Enteroscope And Accessories
Device Class: 2
Physical State: enteroscope and related accessories, may include balloon, mini-scope
Definition: To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: inserted through mouth or laparoscopically
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: small intestine
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device Identifiers
Device Id: 04953170165849
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
