510(k) K955120

HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR by Ethicon Endo-Surgery, Inc. — Product Code GCM

K955120 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, Inc. for the device "HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Ethicon Endo-Surgery, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1996
Date Received
November 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type