BALLOON APPLICATOR

BALLOON APPLICATOR - MAJ-1352

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:

• High-level Disinfectant
• Ethylene Oxide
• Moist Heat or Steam Sterilization

Code: ITX

Device Name: Transducer, Ultrasonic, Diagnostic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1570

Third Party Flag: Y

Medical Specialty: RA

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

Code: EOQ

Device Name: Bronchoscope (Flexible Or Rigid)

Device Class: 2

Physical State: N/A

Definition: A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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: EN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 874.4680

Third Party Flag: N

Medical Specialty: EN

Code: FDS

Device Name: Gastroscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with gastroscope

Definition: To examine or perform procedures in the stomach. 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 orally into the stomach

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: stomach

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170175626

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