Augustine Stylet
FDA 510(k) K910659 · Augustine Medical, Inc.
510(k) numberK910659
Submission
- Device name
- Augustine Stylet
- Applicant
- Augustine Medical, Inc.
Eden Prairie, MN, US - Received
- February 14, 1991
- Decision date
- May 17, 1991
- 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 |
More from Polamedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021473 | Bair Hugger Temperature Management SystemDWJ · Traditional | 07/09/2002SE |
| K020077 | Modification to Augustine Medical Wound Care System, Model 68XXXMSA · Special | 01/31/2002SE |
| K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…DWJ · Traditional | 09/06/2000SE |
| K973741 | Bair Hugger Blood/Fluid WarmerBSB · Traditional | 04/30/1998SE |
| K964673 | Bair Hugger Model 630 Cardiac BlanketDWJ · Traditional | 06/26/1997SE |
| K963293 | Augustine Medical Wound Care System Model 68XXXMSA · Traditional | 03/28/1997SN |
| K963672 | Model 90022 Rolling StandJOW · Traditional | 01/06/1997SE |
| K960167 | System, Thermal Regulating 74-DWJDWJ · Traditional | 06/17/1996SE |
| K954446 | Augustine Intubation GuideCCW · Traditional | 12/29/1995SE |
| K952864 | Bair Hugger Model 655 BlanketDWJ · Traditional | 09/12/1995SE |
Questions and answers
When was Augustine Stylet cleared by the FDA?
Augustine Stylet (K910659) received a 510(k) decision of Substantially Equivalent on May 17, 1991, 92 days after the submission was received.
What is the product code of K910659?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.