510(k) K072691

CERVICAL MD, MODEL C10 by Sti Medical Systems — Product Code HEX

K072691 is an FDA 510(k) premarket notification submitted by Sti Medical Systems for the device "CERVICAL MD, MODEL C10". The FDA issued a decision of Substantially Equivalent on January 31, 2008. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Sti Medical Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2008
Date Received
September 24, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colposcope (And Colpomicroscope)
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type