Balloon Applicator

Balloon Applicator - MAJ-564

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: True

Sterilization Methods:

• Ethylene Oxide
• High-level Disinfectant

Code: FED

Device Name: Endoscopic Access Overtube, Gastroenterology-Urology

Device Class: 2

Physical State: overtube

Definition: To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Endoscope inserted and advanced through center of device

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various openings in gi and gu tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

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: 04953170368547

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