510(k) K200757
K200757 is an FDA 510(k) premarket notification submitted by Deroyal Industries, Inc. for the device "Foley Catheter with Temperature Sensor". The FDA issued a decision of Substantially Equivalent on October 15, 2020. The device falls under product code EYC (Catheter, Upper Urinary Tract), a Class II device regulated under 21 CFR 876.5130. Deroyal Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2020
- Date Received
- March 24, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Upper Urinary Tract
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type