510(k) K170233
K170233 is an FDA 510(k) premarket notification submitted by Zhanjiang Star Enterprise Co., Ltd. for the device "Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)". The FDA issued a decision of Substantially Equivalent on Oct 13, 2017. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Zhanjiang Star Enterprise Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 2017
- Date Received
- Jan 25, 2017
- 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
- 510(k)