510(k) K901464

MEDILASE SERIES 2200 ENDOSCOPE by Medical Laser, Inc. — Product Code GCM

K901464 is an FDA 510(k) premarket notification submitted by Medical Laser, Inc. for the device "MEDILASE SERIES 2200 ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on August 7, 1990. The device falls under product code GCM (Endoscope, Rigid), 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
August 7, 1990
Date Received
March 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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