510(k) K812291

ETHICON MULTIPLE LIGATING CLIP APPLIER by ETHICON, Inc. — Product Code GDO

K812291 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "ETHICON MULTIPLE LIGATING CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on September 11, 1981. The device falls under product code GDO (Applier, Surgical, Clip), a Class I device regulated under 21 CFR 878.4800. ETHICON, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1981
Date Received
August 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Surgical, Clip
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type