Silicone Laryngeal Stent
FDA 510(k) K884810 · Hood Laboratories
510(k) numberK884810
Submission
- Device name
- Silicone Laryngeal Stent
- Applicant
- Hood Laboratories
Pembroke, MA, US - Received
- November 17, 1988
- Decision date
- May 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K091135 | Rutter Supra Stomal StentsFWN · Traditional | Boston Medical Products, Inc. | 09/14/2009SE |
| 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 |
| 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 |
|---|---|---|
| K921452 | Acoustic RhinometerBXQ · Traditional | 07/08/1993SE |
| K920994 | Hood Nasal Septal ButtonLFB · Traditional | 05/15/1992SE |
| K905703 | Krupin Eye Valve with DiskKYF · Traditional | 03/15/1991SE |
| K904821 | Eliachar Modified Esophageal StentESW · Traditional | 01/14/1991SE |
| K897049 | Gibson Endolymphatic ShuntESZ · Traditional | 03/16/1990SE |
| K897059 | Hood Speaking ValveJOH · Traditional | 03/12/1990SE |
| K893866 | Hood Pediatric Tracheostomy TubeBTO · Traditional | 08/07/1989SE |
| K890599 | Hood Nasal SplintEPP · Traditional | 03/17/1989SE |
| K885125 | Krupin Eye Valve W/Scleral BuckleKYF · Traditional | 01/24/1989SE |
| K882430 | Hood Tracheal Stoma ButtonBTO · Traditional | 06/28/1988SE |
Questions and answers
When was Silicone Laryngeal Stent cleared by the FDA?
Silicone Laryngeal Stent (K884810) received a 510(k) decision of Substantially Equivalent on May 10, 1989, 174 days after the submission was received.
What is the product code of K884810?
The FDA product code is FWN – Prosthesis, Larynx (Stents And Keels), a Class II (moderate risk) device regulated under 21 CFR 874.3620.