510(k) K122785
K122785 is an FDA 510(k) premarket notification submitted by Rochester Medical Corp. for the device "HYDROSIL; MAGIC; PERSONAL CATHETER". The FDA issued a decision of Substantially Equivalent on May 14, 2013. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Rochester Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2013
- Date Received
- September 11, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type