Cleared Traditional

1.1 SCREWDRIVERS

K872490 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery
Jul 1987
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K872490 is an FDA 510(k) clearance for the 1.1 SCREWDRIVERS, a Screwdriver, Surgical (Class I — General Controls, product code LRZ), submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on July 23, 1987, 30 days after receiving the submission on June 23, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K872490 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1987
Decision Date July 23, 1987
Days to Decision 30 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