510(k) K071745
K071745 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE". The FDA issued a decision of Substantially Equivalent on July 19, 2007. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2007
- Date Received
- June 27, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Radiofrequency Lesion
- Device Class
- Class II
- Regulation Number
- 882.4725
- Review Panel
- NE
- Submission Type