K183525 is an FDA 510(k) clearance for the EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F. This device is classified as a Ultrasound Bronchoscope (Class II - Special Controls, product code PSV).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on September 6, 2019, 261 days after receiving the submission on December 19, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 892.1550. An Ultrasound Bronchoscope Is Indicated For The Ultrasonic Visualization, Diagnosis And Therapeutic Access To The Bronchial Tree Or The Lungs. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K183525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2018 |
| Decision Date | September 06, 2019 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | PSV — Ultrasound Bronchoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
| Definition | An Ultrasound Bronchoscope Is Indicated For The Ultrasonic Visualization, Diagnosis And Therapeutic Access To The Bronchial Tree Or The Lungs. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |