510(k) K133687
K133687 is an FDA 510(k) premarket notification submitted by Thd Spa for the device "THD N-ANO ANOSCOPE". The FDA issued a decision of Substantially Equivalent on Dec 11, 2013. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Thd Spa has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 11, 2013
- Date Received
- Dec 2, 2013
- Clearance Type
- Special
- 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
- 510(k)
To examine and perform procedures within the anus and rectum.