K192498 is an FDA 510(k) clearance for the Single Use Injector. This device is classified as a Endoscopic Injection Needle, Gastroenterology-urology (Class II - Special Controls, product code FBK).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on April 28, 2020, 230 days after receiving the submission on September 11, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue..
| 510(k) Number | K192498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2019 |
| Decision Date | April 28, 2020 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBK — Endoscopic Injection Needle, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue. |