510(k) K900781
K900781 is an FDA 510(k) premarket notification submitted by Applied Urology, Inc. for the device "WORKING CHANNEL VALVE". The FDA issued a decision of Substantially Equivalent on April 25, 1990. The device falls under product code FFY (Adaptor, Bulbs, Miscellaneous, For Endoscope), a Class I device regulated under 21 CFR 876.1500. Applied Urology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1990
- Date Received
- February 20, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Bulbs, Miscellaneous, For Endoscope
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type