510(k) K132181
K132181 is an FDA 510(k) premarket notification submitted by Olympus Surgical Technologies America for the device "GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on October 21, 2013. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Olympus Surgical Technologies America has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2013
- Date Received
- July 15, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Catheter, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.5470
- Review Panel
- GU
- Submission Type