510(k) K103647
K103647 is an FDA 510(k) premarket notification submitted by Thd Spa for the device "THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES". The FDA issued a decision of Substantially Equivalent on March 1, 2011. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Thd Spa has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2011
- Date Received
- December 13, 2010
- 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
To examine and perform procedures within the anus and rectum.