K060475 is an FDA 510(k) clearance for the EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8. This device is classified as a Endoscopic Contamination Prevention Sheath (Class II - Special Controls, product code ODB).
Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on March 17, 2006, 22 days after receiving the submission on February 23, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 876.1500. To Protect An Endoscope From Contamination By Providing A Barrier Between The Body And The Endoscope..
| 510(k) Number | K060475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2006 |
| Decision Date | March 17, 2006 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | ODB — Endoscopic Contamination Prevention Sheath |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Protect An Endoscope From Contamination By Providing A Barrier Between The Body And The Endoscope. |