510(k) K062720

S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES by Richard Wolf Medical Instruments Corp. — Product Code FJL

K062720 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES". The FDA issued a decision of Substantially Equivalent on March 22, 2007. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2007
Date Received
September 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type