Cleared Traditional

K864019 - NEEDLE NOSE PLIERS
(FDA 510(k) Clearance)

K864019 · Med-Tool, Inc. · General & Plastic Surgery device

Oct 1986

Decision

15d

Days

Class 1

Risk

K864019 is an FDA 510(k) clearance for the NEEDLE NOSE PLIERS. This device is classified as 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 October 30, 1986, 15 days after receiving the submission on October 15, 1986.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K864019 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 1986
Decision Date	October 30, 1986
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—