510(k) K942389

TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES by Hogan & Hartson — Product Code HET

K942389 is an FDA 510(k) premarket notification submitted by Hogan & Hartson for the device "TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES". The FDA issued a decision of Substantially Equivalent on February 16, 1996. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Hogan & Hartson has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1996
Date Received
May 18, 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