510(k) K190164
K190164 is an FDA 510(k) premarket notification submitted by Olympus Surgical Technologies America for the device "CleverLock Guidewire Locking Device and Biopsy Cap". The FDA issued a decision of Substantially Equivalent on April 4, 2019. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Olympus Surgical Technologies America has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2019
- Date Received
- January 31, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Channel Accessory
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To give the endoscope channel additional or improved functionality.