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510(k) K023173

ANDREWS INTRODUCER, MODEL ASI01 by Andrews Surgical Innovations, Ltd. — Product Code MDM

K023173 is an FDA 510(k) premarket notification submitted by Andrews Surgical Innovations, Ltd. for the device "ANDREWS INTRODUCER, MODEL ASI01". The FDA issued a decision of Substantially Equivalent on December 18, 2002. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2002
Date Received
September 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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FDA data resources