FOOT RELEASE

FOOT RELEASE - MB-332

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: FDT

Device Name: Duodenoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with duodenoscope

Definition: To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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 orally into duodenum

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: duodenum, esophagus

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170022975

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