Cleared Traditional

K844600 - SLIP JOINT PLIERS
(FDA 510(k) Clearance)

Dec 1984
Decision
17d
Days
Class 1
Risk

K844600 is an FDA 510(k) clearance for the SLIP JOINT 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 December 14, 1984, 17 days after receiving the submission on November 27, 1984.

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

Submission Details

510(k) Number K844600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date December 14, 1984
Days to Decision 17 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