Blom-Singer Voice Prosthesis Flushing Pipet
FDA 510(k) K932163 · Helix Medical, Inc.
510(k) numberK932163
Submission
- Device name
- Blom-Singer Voice Prosthesis Flushing Pipet
- Applicant
- Helix Medical, Inc.
Santa Barbera, CA, US - Received
- May 4, 1993
- Decision date
- December 15, 1993
- 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 |
| 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 |
|---|---|---|
| K130736 | Blom-Singer Adjustable Bi-Fianged Fistula ProsthesisLRC · Traditional | 12/17/2013SE |
| K131745 | Blom-Singer Septal Perforation ProsthesisLFB · Traditional | 09/17/2013SE |
| K093258 | Blom-Singer Indwelling Tep OccluderEWL · Special | 03/03/2010SE |
| K082206 | Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesEWL · Special | 09/04/2008SE |
| K023259 | Inhealth Soft Sleeve Colonoscope Splint, Model CS1200FDF · Traditional | 12/26/2002SE |
| K991587 | Blom-Singer Indwelling 2000 Voice ProsthesisEWL · Traditional | 06/25/1999SE |
| K945287 | Inhealth Blom-Singer Indwelling Valved Insert Accessory DeviceEWL · Traditional | 12/09/1994SE |
| K945288 | Inhealth Blom-Singer Indwelling Plug Insert Accessory DeviceEWL · Traditional | 12/02/1994SE |
| K932120 | Blom-Singer Indwelling Low Pressure Voice ProsthesEWL · Traditional | 04/15/1994SE |
| K930105 | Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S.EWL · Traditional | 05/17/1993SE |
Questions and answers
When was Blom-Singer Voice Prosthesis Flushing Pipet cleared by the FDA?
Blom-Singer Voice Prosthesis Flushing Pipet (K932163) received a 510(k) decision of Substantially Equivalent on December 15, 1993, 225 days after the submission was received.
What is the product code of K932163?
The FDA product code is EWL – Prosthesis, Laryngeal (Taub), a Class II (moderate risk) device regulated under 21 CFR 874.3730.