510(k) K900894

MEDILASE SERIES 2100 ENDOSCOPE by Medical Laser, Inc. — Product Code GCQ

K900894 is an FDA 510(k) premarket notification submitted by Medical Laser, Inc. for the device "MEDILASE SERIES 2100 ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on June 22, 1990. The device falls under product code GCQ (Endoscope, Flexible), a Class II device regulated under 21 CFR 876.1500. Medical Laser, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1990
Date Received
February 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Flexible
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type