510(k) K071745

BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE by Baylis Medical Co., Inc. — Product Code GXI

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