510(k) K192498
K192498 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Injector". The FDA issued a decision of Substantially Equivalent on April 28, 2020. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2020
- Date Received
- September 11, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.