Panje Voice Prosthesis
FDA 510(k) K810020 · Xomed, Inc.
510(k) numberK810020
Submission
- Device name
- Panje Voice Prosthesis
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- January 5, 1981
- Decision date
- February 5, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EWL – Prosthesis, Laryngeal (Taub)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3730
- Specialty
- Ear, Nose, Throat
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| K092593 | Provox Activalve (Size 4.5MM, 6MM, 8MM, 10MM, 12.5MM)EWL · Traditional | Atos Medical AB | 10/14/2010SESK |
| K093258 | Blom-Singer Indwelling Tep OccluderEWL · Special | Helix Medical, LLC | 03/03/2010SE |
| K090455 | Provox Vega, Model 8130-8135EWL · Traditional | Atos Medical AB | 06/05/2009SE |
| K082206 | Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesEWL · Special | Helix Medical, LLC | 09/04/2008SE |
| K043138 | Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134EWL · Special | Atos Medical AB | 11/22/2004SE |
| K022125 | Provox Freehands Hme, Model 7710EWL · Special | Atos Medical AB | 07/30/2002SE |
| K991587 | Blom-Singer Indwelling 2000 Voice ProsthesisEWL · Traditional | Helix Medical, Inc. | 06/25/1999SE |
More from Helix Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
| K002987 | Redtronic Xomed Monopolar Energized BladeGEI · Traditional | 12/04/2000SE |
| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Panje Voice Prosthesis cleared by the FDA?
Panje Voice Prosthesis (K810020) received a 510(k) decision of Substantially Equivalent on February 5, 1981, 31 days after the submission was received.
What is the product code of K810020?
The FDA product code is EWL – Prosthesis, Laryngeal (Taub), a Class II (moderate risk) device regulated under 21 CFR 874.3730.