510(k) K090432
K090432 is an FDA 510(k) premarket notification submitted by Angiologica B. M. Srl for the device "HEMORPEX SYSTEM". The FDA issued a decision of Substantially Equivalent on May 29, 2009. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Angiologica B. M. Srl has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2009
- Date Received
- February 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anoscope And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To examine and perform procedures within the anus and rectum.