510(k) K161106

PANPAC DISPOSABLE VACUUM CURETTES by Panpac Medical Corporation — Product Code HGH

K161106 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "PANPAC DISPOSABLE VACUUM CURETTES". The FDA issued a decision of Substantially Equivalent on January 13, 2017. The device falls under product code HGH (Cannula, Suction, Uterine), a Class II device regulated under 21 CFR 884.5070. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2017
Date Received
April 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Suction, Uterine
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type