510(k) K881014

THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM by KARL STORZ Endoscopy-America, Inc. — Product Code FWF

K881014 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1988
Date Received
March 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Television, Endoscopic, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type