510(k) K123956

POWER LED 175 by KARL STORZ Endoscopy-America, Inc. — Product Code FCW

K123956 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "POWER LED 175". The FDA issued a decision of Substantially Equivalent on January 25, 2013. The device falls under product code FCW (Light Source, Fiberoptic, Routine), 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
January 25, 2013
Date Received
December 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type