510(k) K944268

CIT TWO WAY SUCTIN AND IRRIGATION TUBES by Chirurgische Instrumente — Product Code HET

K944268 is an FDA 510(k) premarket notification submitted by Chirurgische Instrumente for the device "CIT TWO WAY SUCTIN AND IRRIGATION TUBES". The FDA issued a decision of Substantially Equivalent on January 26, 1995. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Chirurgische Instrumente has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1995
Date Received
September 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type