510(k) K935070

GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS by KARL STORZ Endoscopy-America, Inc. — Product Code FCL

K935070 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS". The FDA issued a decision of Substantially Equivalent on January 25, 1994. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. 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, 1994
Date Received
October 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
Submission Type