K212201 is an FDA 510(k) clearance for the PENTAX Medical Auto Leakage Tester SHA-P6. This device is classified as a Endoscopic Leak Tester (Class II - Special Controls, product code PCV).
Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on October 1, 2021, 79 days after receiving the submission on July 14, 2021.
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 | K212201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2021 |
| Decision Date | October 01, 2021 |
| Days to Decision | 79 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. |