Rusch Endotracheal Tube Stylet
FDA 510(k) K952100 · Rusch, Inc.
510(k) numberK952100
Submission
- Device name
- Rusch Endotracheal Tube Stylet
- Applicant
- Rusch, Inc.
Jeffrey, NH, US - Received
- May 4, 1995
- Decision date
- August 8, 1995
- 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
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|---|---|---|---|
| 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 |
| K955238 | Rusch Schroeder Endotracheal Tube StyleBSR · Traditional | Rusch Intl. | 02/06/1996SE |
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | Scientific Sales Intl., Inc. | 08/25/1995SE |
| 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 |
|---|---|---|
| K010420 | Rusch Mmg/O'Neil CatheterFCM · Traditional | 05/09/2001SE |
| K993528 | Rusch Emergency MaskCBP · Traditional | 05/31/2000SE |
| K993194 | Rusch Manual Resuscitator BagBTM · Traditional | 03/24/2000SE |
| K980870 | Rusch Silicone Foley CatheterEZL · Traditional | 06/09/1998SE |
| K974419 | Rusch Simplastic Councill Tip CatheterEZL · Traditional | 01/27/1998SE |
| K963779 | Rusch Enteral Feeding TubeFPD · Traditional | 05/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | 02/07/1997SE |
| K963993 | Rusch Simplastic Foley Catheterization SetFCM · Traditional | 12/17/1996SE |
| K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileJOH · Traditional | 06/28/1996SE |
| K955495 | Rusch Reinforced Trachael Tube Cuffed, SterileBTR · Traditional | 06/27/1996SE |
Questions and answers
When was Rusch Endotracheal Tube Stylet cleared by the FDA?
Rusch Endotracheal Tube Stylet (K952100) received a 510(k) decision of Substantially Equivalent on August 8, 1995, 96 days after the submission was received.
What is the product code of K952100?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.