K080132 is an FDA 510(k) clearance for the THD DISPOSABLE ANOSCOPE/PROCTOSCOPE. This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Thd Spa (S. Lazzaro Di Savena, Bologna, IT). The FDA issued a Cleared decision on April 9, 2008, 82 days after receiving the submission on January 18, 2008.
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 | K080132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2008 |
| Decision Date | April 09, 2008 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| 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. |