Rutter Supra Stomal Stents
FDA 510(k) K091135 · Boston Medical Products, Inc.
510(k) numberK091135
Submission
- Device name
- Rutter Supra Stomal Stents
- Applicant
- Boston Medical Products, Inc.
Westborough, MA, US - Received
- April 20, 2009
- Decision date
- September 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FWN – Prosthesis, Larynx (Stents And Keels)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code FWN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000154 | Eliachar Laryngeal Foam Stent, Model ELL-1FWN · Traditional | E. Benson Hood Lab, Inc. | 03/29/2000SE |
| K962693 | Montgomery Radiopaque Laryngeal KeelFWN · Traditional | Boston Medical Products, Inc. | 08/09/1996SE |
| K896667 | Lorenz StentFWN · Traditional | Walter Lorenz Surgical, Inc. | 02/22/1990SE |
| K884810 | Silicone Laryngeal StentFWN · Traditional | Hood Laboratories | 05/10/1989SE |
| K864936 | 'Exmoor' Das Gupta Laryngeal KeelFWN · Traditional | Exmoor Plastics , Ltd. | 04/27/1987SE |
| K853726 | LaryngealFWN · Traditional | Hood Laboratories | 03/12/1986SE |
| K842800 | Montg. Laryngeal KeelFWN · Traditional | Boston Medical Products, Inc. | 08/02/1984SE |
| K842287 | Montgomery Laryngeal StentFWN · Traditional | Boston Medical Products, Inc. | 06/27/1984SE |
| K841347 | Laryngeal StentFWN · Traditional | E. Benson Hood Laboratories, Inc. | 05/02/1984SE |
More from E. Benson Hood Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972317 | Montgomery Thyroplasty Implant SystemMIX · Traditional | 09/18/1997SE |
| K972459 | Rhinocell Nasal PackingsEMX · Traditional | 08/04/1997SE |
| K972096 | Bivalve Nasal SplintLYA · Traditional | 07/15/1997SE |
| K972078 | Post-Stop Epistaxis CatheterEMX · Traditional | 07/10/1997SE |
| K972092 | Nasal Airway SplintLYA · Traditional | 07/08/1997SE |
| K972151 | Doyle Combo Nasal Airway SplintLYA · Traditional | 07/07/1997SE |
| K972082 | Custom Nasal SplintLYA · Traditional | 07/03/1997SE |
| K972060 | Nasal Septal ButtonLFB · Traditional | 07/03/1997SE |
| K972077 | Epi-Stop Epistaxis CatheterEMX · Traditional | 06/26/1997SE |
| K972076 | Epi-Max Epistaxis CatheterEMX · Traditional | 06/26/1997SE |
Questions and answers
When was Rutter Supra Stomal Stents cleared by the FDA?
Rutter Supra Stomal Stents (K091135) received a 510(k) decision of Substantially Equivalent on September 14, 2009, 147 days after the submission was received.
What is the product code of K091135?
The FDA product code is FWN – Prosthesis, Larynx (Stents And Keels), a Class II (moderate risk) device regulated under 21 CFR 874.3620.