510(k) K051505

SCB/STERIS OR-LIGHT INTERFACE BOX by KARL STORZ Endoscopy-America, Inc. — Product Code FTA

K051505 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "SCB/STERIS OR-LIGHT INTERFACE BOX". The FDA issued a decision of Substantially Equivalent on August 11, 2005. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2005
Date Received
June 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Accessories
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type