510(k) K902097

MODEL TR RECTAL SUCTION BIOPSY TUBE by Medical Measurements, Inc. — Product Code FCK

K902097 is an FDA 510(k) premarket notification submitted by Medical Measurements, Inc. for the device "MODEL TR RECTAL SUCTION BIOPSY TUBE". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. Medical Measurements, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1990
Date Received
May 8, 1990
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