510(k) K911475

LAPAROSCOPIC VESSEL ARTICULATOR by United States Endoscopy Group, Inc. — Product Code DWP

K911475 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "LAPAROSCOPIC VESSEL ARTICULATOR". The FDA issued a decision of Substantially Equivalent on July 2, 1991. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1991
Date Received
April 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type