K881469 is an FDA 510(k) clearance for the ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL. This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on September 12, 1988, 158 days after receiving the submission on April 7, 1988.
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 | K881469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1988 |
| Decision Date | September 12, 1988 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| 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. |