510(k) K810787
K810787 is an FDA 510(k) premarket notification submitted by The Urology Group for the device "UROLOGIC TUBE HOLDER". The FDA issued a decision of Substantially Equivalent on March 31, 1981. The device falls under product code OCV (Endoscope Holder), a Class II device regulated under 21 CFR 876.1500. The Urology Group has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1981
- Date Received
- March 23, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Holder
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To hold endoscope in a desired position during procedures.