510(k) K051950

INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 by Ethicon Endo-Surgery, Inc. — Product Code MND

K051950 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, Inc. for the device "INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321". The FDA issued a decision of Substantially Equivalent on October 7, 2005. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. Ethicon Endo-Surgery, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2005
Date Received
July 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Esophageal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type