K091490 is an FDA 510(k) clearance for the FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES. This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Thd Spa (Imoa, IT). The FDA issued a Cleared decision on June 11, 2009, 22 days after receiving the submission on May 20, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine And Perform Procedures Within The Anus And Rectum..
| 510(k) Number | K091490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2009 |
| Decision Date | June 11, 2009 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FER - Anoscope And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform Procedures Within The Anus And Rectum. |