Cleared Traditional

TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)

K954771 · Laerdal Medical Corp. · Anesthesiology
May 1996
Decision
205d
Days
Class 1
Risk

About This 510(k) Submission

K954771 is an FDA 510(k) clearance for the TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND), a Stylet, Tracheal Tube (Class I — General Controls, product code BSR), submitted by Laerdal Medical Corp. (Wappingers Falls, US). The FDA issued a Cleared decision on May 9, 1996, 205 days after receiving the submission on October 17, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5790.

Submission Details

510(k) Number K954771 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1995
Decision Date May 09, 1996
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSR — Stylet, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5790

Similar Devices — BSR Stylet, Tracheal Tube

All 31
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
K162729 · Cook Incorporated · Aug 2017
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
K962361 · Laerdal Medical Corp. · Sep 1996
MOLLOY INTUBATING STYLETTE
K943104 · Molloy Corp. · Apr 1996
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
K955238 · Rusch Intl. · Feb 1996
LIGHTED FLEXGUIDE (MODIFICATION)
K953677 · Scientific Sales Intl., Inc. · Aug 1995
RUSCH ENDOTRACHEAL TUBE STYLET
K952100 · Rusch, Inc. · Aug 1995