K123704 is an FDA 510(k) clearance for the AUTOMATED ENDOSCOPE LEAK TESTER. This device is classified as a Endoscopic Leak Tester (Class II — Special Controls, product code PCV).
Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on February 4, 2013, 63 days after receiving the submission on December 3, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. An Endoscopic Leak Tester Automatically Detects Leaks From Endoscopes, Without Requiring Visual Observation For Bubbles When The Device Is Immersed In Water, By Assessing Differences In Air Pressure Inside The Pressurized Endoscope..
| 510(k) Number | K123704 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 2012 |
| Decision Date | February 04, 2013 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PCV — Endoscopic Leak Tester |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | An Endoscopic Leak Tester Automatically Detects Leaks From Endoscopes, Without Requiring Visual Observation For Bubbles When The Device Is Immersed In Water, By Assessing Differences In Air Pressure Inside The Pressurized Endoscope. |