510(k) K173559
K173559 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Barrx SB RFA Endoscopic Catheter". The FDA issued a decision of Substantially Equivalent on Jan 18, 2018. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Covidien, LLC has 224 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2018
- Date Received
- Nov 17, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type
- 510(k)