K171701 is an FDA 510(k) clearance for the GelPOINT Path Transanal Access Platform. This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on July 20, 2017, 42 days after receiving the submission on June 8, 2017.
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 | K171701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2017 |
| Decision Date | July 20, 2017 |
| Days to Decision | 42 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. |