510(k) K820837

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

K820837 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "DISPOSABLE MULTIPLE LIGATING CLIP". The FDA issued a decision of Substantially Equivalent on May 28, 1982. 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
May 28, 1982
Date Received
March 26, 1982
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