PROBE ARM SET B

PROBE ARM SET B - MAJ-1153

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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