Duckbill Voice Prosthesis & Tracheo
FDA 510(k) K832967 · American V. Mueller
510(k) numberK832967
Submission
- Device name
- Duckbill Voice Prosthesis & Tracheo
- Applicant
- American V. Mueller
Mchenry, IL, US - Received
- September 1, 1983
- Decision date
- December 23, 1983
- 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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| K240763 | FirstFit Surgical KitEWL · Traditional | Freudenberg Medical, LLC | 12/18/2024SE |
| K141380 | Provox Freehands FlexivoiceEWL · Traditional | Atos Medical AB | 09/26/2014SE |
| 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 |
More from Helix Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873771 | Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional | 12/18/1987SE |
| K873332 | Maxivac(Tm) Closed Wound Suction Drainage SystemGCY · Traditional | 09/08/1987SE |
| K871685 | Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt SysJXG · Traditional | 06/12/1987SE |
| K864676 | Heyer-Schulte Hermetic External CSF Drain. SystemJXG · Traditional | 12/29/1986SE |
| K862772 | V. Mueller (R) Gooseneck Circular StaplerGAG · Traditional | 08/18/1986SE |
| K861471 | V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional | 06/06/1986SE |
| K854568 | V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional | 12/02/1985SE |
| K854049 | Heyer-Schulte Syringo Peritoneal ShuntJXG · Traditional | 11/27/1985SE |
| K851082 | V. Mueller Blom-Singer Esophageal Insufflation TesENW · Traditional | 07/22/1985SE |
| K851974 | V. Mueller Vital Skin StaplerGDT · Traditional | 06/11/1985SE |
Questions and answers
When was Duckbill Voice Prosthesis & Tracheo cleared by the FDA?
Duckbill Voice Prosthesis & Tracheo (K832967) received a 510(k) decision of Substantially Equivalent on December 23, 1983, 113 days after the submission was received.
What is the product code of K832967?
The FDA product code is EWL – Prosthesis, Laryngeal (Taub), a Class II (moderate risk) device regulated under 21 CFR 874.3730.