510(k) K970110
K970110 is an FDA 510(k) premarket notification submitted by Bard Medical Div. for the device "BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)". The FDA issued a decision of Substantially Equivalent on February 19, 1997. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Bard Medical Div. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1997
- Date Received
- January 13, 1997
- Clearance Type
- Traditional
- 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.