Intubation Procedure Kit
FDA 510(k) K772046 · American Hospital Supply Corp.
510(k) numberK772046
Submission
- Device name
- Intubation Procedure Kit
- Applicant
- American Hospital Supply Corp.
Mchenry, IL, US - Received
- October 28, 1977
- Decision date
- November 23, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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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|---|---|---|
| K854739 | American Sterile Surgical Absorbent Towel · Traditional | 12/27/1985SE |
| K854759 | American Sterile Mayo Stand Tray · Traditional | 12/17/1985SE |
| K832826 | Aap Dosimetry Release or Basin SetsFNY · Traditional | 04/23/1984SE |
| K830546 | Dosimetric ReleaseKQT · Traditional | 05/25/1983SE |
| K822990 | Convertors Primary Wound Dressing IIFRO · Traditional | 04/12/1983SE |
| K830343 | Container W/Priming SolutionKDP · Traditional | 03/17/1983SE |
| K830301 | Stratus Fluorometric Enzyme IMMUN0-JJE · Traditional | 02/25/1983SE |
| K822755 | Latex Penrose Tubing · Traditional | 01/21/1983SE |
| K823418 | Heyer-Schute Universal Ureteral StentLJE · Traditional | 12/03/1982SE |
| K822966 | Convertors Disposable Dressing SpongeNAB · Traditional | 11/05/1982SE |
Questions and answers
When was Intubation Procedure Kit cleared by the FDA?
Intubation Procedure Kit (K772046) received a 510(k) decision of Substantially Equivalent on November 23, 1977, 26 days after the submission was received.
What is the product code of K772046?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.