Cleared Traditional

STANDARD SCREW DRIVER

K872387 · Med-Tool, Inc. · General & Plastic Surgery
Jul 1987
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K872387 is an FDA 510(k) clearance for the STANDARD SCREW DRIVER, a Screwdriver, Surgical (Class I — General Controls, product code LRZ), submitted by Med-Tool, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 16, 1987, 27 days after receiving the submission on June 19, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K872387 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1987
Decision Date July 16, 1987
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code LRZ — Screwdriver, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800