510(k) K041321

VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM by Richard Wolf Medical Instruments Corp. — Product Code HET

K041321 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 2004. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2004
Date Received
May 18, 2004
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