510(k) K984607

PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX by Richard Wolf Medical Instruments Corp. — Product Code FBP

K984607 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX". The FDA issued a decision of Substantially Equivalent on March 5, 1999. The device falls under product code FBP (Telescope, Rigid, Endoscopic), 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 5, 1999
Date Received
December 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Telescope, Rigid, Endoscopic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type