K951577 is an FDA 510(k) clearance for the ES-3800, VIDEO SIGMOIDOSCOPE. This device is classified as a Sigmoidoscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FAM).
Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on March 21, 1996, 352 days after receiving the submission on April 4, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine And Perform Procedures Within The Sigmoid (descending) Colon.
| 510(k) Number | K951577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1995 |
| Decision Date | March 21, 1996 |
| Days to Decision | 352 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAM — Sigmoidoscope And Accessories, Flexible/rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform Procedures Within The Sigmoid (descending) Colon |