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510(k) K000252

INSIGHT 4000 ENDOSCOPE by Insight Instruments Mfg., Inc. — Product Code MPA

K000252 is an FDA 510(k) premarket notification submitted by Insight Instruments Mfg., Inc. for the device "INSIGHT 4000 ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on October 17, 2000. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2000
Date Received
January 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

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FDA data resources