Cleared Traditional

MOLLOY INTUBATING STYLETTE

K943104 · Molloy Corp. · Anesthesiology

Apr 1996

Decision

659d

Days

Class 1

Risk

About This 510(k) Submission

K943104 is an FDA 510(k) clearance for the MOLLOY INTUBATING STYLETTE, a Stylet, Tracheal Tube (Class I — General Controls, product code BSR), submitted by Molloy Corp. (Lebanon, US). The FDA issued a Cleared decision on April 18, 1996, 659 days after receiving the submission on June 29, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5790.

Submission Details

510(k) Number	K943104 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 1994
Decision Date	April 18, 1996
Days to Decision	659 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement