Biopsy Valve - MAJ-853
Device Description
A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- High-level Disinfectant
- Moist Heat or Steam Sterilization
Product Codes
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 IdentifiersDevice Id: 04953170062209
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