510(k) K934730

KARL STORZ ENDOSCOPIC COLD KNIFE BLADES by KARL STORZ Endoscopy-America, Inc. — Product Code EZO

K934730 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ ENDOSCOPIC COLD KNIFE BLADES". The FDA issued a decision of Substantially Equivalent on January 11, 1994. The device falls under product code EZO (Urethrotome), a Class II device regulated under 21 CFR 876.4770. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1994
Date Received
October 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urethrotome
Device Class
Class II
Regulation Number
876.4770
Review Panel
GU
Submission Type