Cleared Traditional

WIRE CUTTING PLIERS OR LINEMAN'S PLIERS

K854390 · Med-Tool, Inc. · General & Plastic Surgery
Nov 1985
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K854390 is an FDA 510(k) clearance for the WIRE CUTTING PLIERS OR LINEMAN'S PLIERS, a Pliers, Surgical (Class I — General Controls, product code HTC), submitted by Med-Tool, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 19, 1985, 19 days after receiving the submission on October 31, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K854390 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1985
Decision Date November 19, 1985
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HTC — Pliers, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800