Tracheal Tube Stylet

FDA 510(k) K902180 · Sims Surgical, Inc.

Substantially Equivalent

510(k) numberK902180

Submission

Device name
Tracheal Tube Stylet
Applicant
Sims Surgical, Inc.
Keene, NH, US
Received
May 15, 1990
Decision date
July 19, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BSR – Stylet, Tracheal Tube
Device class
Class I (low risk)
Regulation
21 CFR 868.5790
Specialty
Anesthesiology

Other 510(k)s with product code BSR

510(k)DeviceApplicantDecision
K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange…BSR · Traditional Cook Incorporated08/11/2017SE
K962361Trachlight Stylet and Tracheal LightwandBSR · Traditional Laerdal Medical Corp.09/05/1996SE
K954771Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal…BSR · Traditional Laerdal Medical Corp.05/09/1996SE
K943104Molloy Intubating StyletteBSR · Traditional Molloy Corp.04/18/1996SE
K955238Rusch Schroeder Endotracheal Tube StyleBSR · Traditional Rusch Intl.02/06/1996SE
K953677Lighted Flexguide (Modification)BSR · Traditional Scientific Sales Intl., Inc.08/25/1995SE
K952100Rusch Endotracheal Tube StyletBSR · Traditional Rusch, Inc.08/08/1995SE
K952266Schroeder Oral/Nasal Directional StyletteBSR · Traditional Stebar Instrument Corp.06/12/1995SE
K950713Airguide StyletteBSR · Traditional Polamedco, Inc.05/17/1995SE
K950380Flextitip StyletteBSR · Traditional Polamedco, Inc.02/10/1995SE

More from Polamedco, Inc.

510(k)DeviceDecision
K902517Neurosurgical Headframe AccessoriesGZT · Traditional 07/03/1990SE
K902516New Length Sugita AppliersHIC · Traditional 07/03/1990SE

Questions and answers

When was Tracheal Tube Stylet cleared by the FDA?

Tracheal Tube Stylet (K902180) received a 510(k) decision of Substantially Equivalent on July 19, 1990, 65 days after the submission was received.

What is the product code of K902180?

The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.