K181193 is an FDA 510(k) clearance for the PeriView FLEX. This device is classified as a Bronchoscope Accessory (Class II - Special Controls, product code KTI).
Submitted by Olympus Surgical Technologies America (Southborough, US). The FDA issued a Cleared decision on July 3, 2018, 60 days after receiving the submission on May 4, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. 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 | K181193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2018 |
| Decision Date | July 03, 2018 |
| Days to Decision | 60 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KTI — Bronchoscope Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| Definition | 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). |