Provox Freehands Flexivoice
FDA 510(k) K141380 · Atos Medical AB
510(k) numberK141380
Submission
- Device name
- Provox Freehands Flexivoice
- Applicant
- Atos Medical AB
Horby, SE - Received
- May 27, 2014
- Decision date
- September 26, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EWL – Prosthesis, Laryngeal (Taub)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3730
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240763 | FirstFit Surgical KitEWL · Traditional | Freudenberg Medical, LLC | 12/18/2024SE |
| K131947 | Provox Vega Puncture SetEWL · Traditional | Atos Medical AB | 10/18/2013SE |
| 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 |
| K974132 | Voice Master ProsthesisEWL · Traditional | E. Benson Hood Lab, Inc. | 02/25/1998SE |
More from E. Benson Hood Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151404 | ProTrach DualcareJOH · Traditional | 02/12/2016SE |
| K131947 | Provox Vega Puncture SetEWL · Traditional | 10/18/2013SE |
| K092593 | Provox Activalve (Size 4.5MM, 6MM, 8MM, 10MM, 12.5MM)EWL · Traditional | 10/14/2010SESK |
| K090455 | Provox Vega, Model 8130-8135EWL · Traditional | 06/05/2009SE |
| K072582 | Provox Micron HmeJOH · Traditional | 05/30/2008SE |
| K043138 | Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134EWL · Special | 11/22/2004SE |
| K022125 | Provox Freehands Hme, Model 7710EWL · Special | 07/30/2002SE |
| K014102 | Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251JOH · Special | 02/21/2002SE |
| K971244 | Provox 2 Voice Prosthesis SystemEWL · Traditional | 06/06/1997SE |
| K942495 | Sinojet Maxillary Sinus Puncture & Irrigation SystemKAM · Traditional | 02/21/1995SE |
Questions and answers
When was Provox Freehands Flexivoice cleared by the FDA?
Provox Freehands Flexivoice (K141380) received a 510(k) decision of Substantially Equivalent on September 26, 2014, 122 days after the submission was received.
What is the product code of K141380?
The FDA product code is EWL – Prosthesis, Laryngeal (Taub), a Class II (moderate risk) device regulated under 21 CFR 874.3730.