510(k) K080780
K080780 is an FDA 510(k) premarket notification submitted by Epitek, Inc. for the device "ANCHORAGE SCOPE, MODEL 000003". The FDA issued a decision of Substantially Equivalent on July 30, 2008. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Epitek, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2008
- Date Received
- March 19, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cystourethroscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type