510(k) K954693

MEHTA BRONCHIAL BIOSPY DRILL by United States Endoscopy Group, Inc. — Product Code FCK

K954693 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "MEHTA BRONCHIAL BIOSPY DRILL". The FDA issued a decision of Substantially Equivalent on October 23, 1995. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1995
Date Received
October 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy, Suction
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type