510(k) K202566
K202566 is an FDA 510(k) premarket notification submitted by Big Blue Biotech, Inc. for the device "Wiygul Catheter". The FDA issued a decision of Substantially Equivalent on Sep 30, 2020. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2020
- Date Received
- Sep 4, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type
- 510(k)