Endotracheal Tube Stylet
FDA 510(k) K921128 · Eastmed Enterprises, Inc.
510(k) numberK921128
Submission
- Device name
- Endotracheal Tube Stylet
- Applicant
- Eastmed Enterprises, Inc.
Marlton, NJ, US - Received
- March 10, 1992
- Decision date
- June 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSR – Stylet, Tracheal Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5790
- Specialty
- Anesthesiology
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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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
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| K903618 | Robertazzi Nasopharyngeal AirwayBTQ · Traditional | 01/08/1991SE |
| K901489 | Macintosh Laryngoscope Blades (American Profile)CCW · Traditional | 04/10/1990SE |
| K890342 | Airways (Guedel, Berman & Nasopharyngeal Types)BTO · Traditional | 04/27/1989SE |
| K884584 | Tongue Seizing Forceps with & Without Rubber PadsBWB · Traditional | 11/14/1988SE |
| K884073 | Laryngoscope Blade (Robertshaw Style)CCW · Traditional | 10/13/1988SE |
| K884072 | 15 Millimeter Male and Female AdaptersCAI · Traditional | 10/07/1988SE |
| K882433 | Laryngoscope RigidCCW · Traditional | 09/02/1988SE |
| K882434 | Mask, Gas, AnestheticBSJ · Traditional | 06/30/1988SE |
Questions and answers
When was Endotracheal Tube Stylet cleared by the FDA?
Endotracheal Tube Stylet (K921128) received a 510(k) decision of Substantially Equivalent on June 2, 1992, 84 days after the submission was received.
What is the product code of K921128?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.