K134026 is an FDA 510(k) clearance for the ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT. This device is classified as a Spatial Imaging For Display Of Endoscope Position (Class II - Special Controls, product code PGU).
Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on March 7, 2014, 67 days after receiving the submission on December 30, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Detect And Display The Shape Of An Inserted Endoscope..
| 510(k) Number | K134026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2013 |
| Decision Date | March 07, 2014 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PGU — Spatial Imaging For Display Of Endoscope Position |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Detect And Display The Shape Of An Inserted Endoscope. |