510(k) K922460

ORIGIN SECONDARY CANNULA AND TROCAR by Origin Medsystems, Inc. — Product Code GEA

K922460 is an FDA 510(k) premarket notification submitted by Origin Medsystems, Inc. for the device "ORIGIN SECONDARY CANNULA AND TROCAR". The FDA issued a decision of Substantially Equivalent on September 16, 1992. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Origin Medsystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1992
Date Received
May 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type