FOOT SWITCH

FOOT SWITCH - MAJ-679

An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: ODG

Device Name: Endoscopic Ultrasound System, Gastroenterology-Urology

Device Class: 2

Physical State: ultrasound system and system accessories, endoscope

Definition: To provide ultrasonic visualization of body cavities that can be accessed by endoscope. 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: Uses ultrasound to visualize body cavities through endoscope

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various body cavities, hollow organs, and canals in GI and GU tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170062124

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