Rusch Schroeder Endotracheal Tube Style
FDA 510(k) K955238 · Rusch Intl.
510(k) numberK955238
Submission
- Device name
- Rusch Schroeder Endotracheal Tube Style
- Applicant
- Rusch Intl.
Jeffrey, NH, US - Received
- November 14, 1995
- Decision date
- February 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange…BSR · Traditional | Cook Incorporated | 08/11/2017SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | Laerdal Medical Corp. | 09/05/1996SE |
| K954771 | Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal…BSR · Traditional | Laerdal Medical Corp. | 05/09/1996SE |
| K943104 | Molloy Intubating StyletteBSR · Traditional | Molloy Corp. | 04/18/1996SE |
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | Scientific Sales Intl., Inc. | 08/25/1995SE |
| K952100 | Rusch Endotracheal Tube StyletBSR · Traditional | Rusch, Inc. | 08/08/1995SE |
| K952266 | Schroeder Oral/Nasal Directional StyletteBSR · Traditional | Stebar Instrument Corp. | 06/12/1995SE |
| K950713 | Airguide StyletteBSR · Traditional | Polamedco, Inc. | 05/17/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | Polamedco, Inc. | 02/10/1995SE |
| K944729 | Stylet Sheath with Locking Cap and Reusable Battery Operated Light SourceBSR · Traditional | Coast Medical, Inc. | 12/21/1994SE |
More from Coast Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033023 | Intermittent Urethral CathetersKOD · Traditional | 12/23/2003SE |
| K030559 | Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemESW · Traditional | 06/30/2003SE |
| K023666 | Rusch Guided Cholangiography CatheterFGE · Traditional | 06/17/2003SE |
| K023918 | Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessJOH · Traditional | 03/28/2003SE |
| K023964 | Rusch Microlaryngeal TubeBTR · Traditional | 12/23/2002SE |
| K021540 | Rusch Edgar TubeBTR · Traditional | 08/01/2002SE |
| K021764 | Rusch Tracheofix Set, Cuffed and UncuffedBTO · Traditional | 07/23/2002SE |
| K020714 | Rusch Floneil; Flocath IntrogelGBM · Traditional | 07/01/2002SE |
| K010798 | Rusch Cantor TubeKNT · Traditional | 02/26/2002SE |
| K010797 | Rusch Miller-Abbott TubeKNT · Traditional | 02/26/2002SE |
Questions and answers
When was Rusch Schroeder Endotracheal Tube Style cleared by the FDA?
Rusch Schroeder Endotracheal Tube Style (K955238) received a 510(k) decision of Substantially Equivalent on February 6, 1996, 84 days after the submission was received.
What is the product code of K955238?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.