Cleared Traditional

K932139 - LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT
(FDA 510(k) Clearance)

K932139 · Aaron Medical Industries · General & Plastic Surgery

Jul 1993

Decision

87d

Days

Class 2

Risk

K932139 is an FDA 510(k) clearance for the LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT. This device is classified as a Light, Surgical, Instrument (Class II — Special Controls, product code FSQ).

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on July 30, 1993, 87 days after receiving the submission on May 4, 1993.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K932139 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 1993
Decision Date	July 30, 1993
Days to Decision	87 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement