510(k) K934647

KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION by KARL STORZ Endoscopy-America, Inc. — Product Code FJL

K934647 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1994
Date Received
September 29, 1993
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