Cleared Traditional

SALEM/RESCE INTUBATION GUIDE

K802416 · Scientific Sales Intl., Inc. · Anesthesiology
Oct 1980
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K802416 is an FDA 510(k) clearance for the SALEM/RESCE INTUBATION GUIDE, a Stylet, Tracheal Tube (Class I — General Controls, product code BSR), submitted by Scientific Sales Intl., Inc. (Walker, US). The FDA issued a Cleared decision on October 23, 1980, 17 days after receiving the submission on October 6, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5790.

Submission Details

510(k) Number K802416 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1980
Decision Date October 23, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
K954771 · Laerdal Medical Corp. · May 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