510(k) K945686

KARL STORZ KNIVES, CURETTES by KARL STORZ Endoscopy-America, Inc. — Product Code EZO

K945686 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ KNIVES, CURETTES". The FDA issued a decision of Substantially Equivalent on February 13, 1995. 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
February 13, 1995
Date Received
November 21, 1994
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