510(k) K192059
K192059 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "Bio Guard Air/Water & Suction Valves". The FDA issued a decision of Substantially Equivalent on September 17, 2019. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2019
- Date Received
- August 1, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Channel Accessory
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To give the endoscope channel additional or improved functionality.