K961567 is an FDA 510(k) clearance for the ES-3840, 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 June 24, 1996, 62 days after receiving the submission on April 23, 1996.
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 | K961567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 1996 |
| Decision Date | June 24, 1996 |
| Days to Decision | 62 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 |