510(k) K091600
K091600 is an FDA 510(k) premarket notification submitted by Percuvision, LLC for the device "DIRECTVISION GUIDE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 25, 2009. The device falls under product code FGC (Urethroscope), a Class II device regulated under 21 CFR 876.1500. Percuvision, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2009
- Date Received
- June 3, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urethroscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type