Cleared Traditional

TICLIP STERIAL DISPOSABLE

K843589 · Western Medical Products, Inc. · General & Plastic Surgery

Oct 1984

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K843589 is an FDA 510(k) clearance for the TICLIP STERIAL DISPOSABLE, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Western Medical Products, Inc. (Van Nuys, US). The FDA issued a Cleared decision on October 24, 1984, 42 days after receiving the submission on September 12, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number	K843589 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 1984
Decision Date	October 24, 1984
Days to Decision	42 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—