Blom-Singer Septal Perforation Prosthesis
FDA 510(k) K131745 · Helix Medical, LLC
510(k) numberK131745
Submission
- Device name
- Blom-Singer Septal Perforation Prosthesis
- Applicant
- Helix Medical, LLC
Carpinteria, CA, US - Received
- June 13, 2013
- Decision date
- September 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFB – Button, Nasal Septal
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code LFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013696 | Silmed Nasal Septal ButtonLFB · Traditional | Silmed, Inc. | 11/28/2001SE |
| K982667 | Micromedics Nasal Septal ButtonLFB · Traditional | Micromedics, Inc. | 11/24/1998SE |
| K972060 | Nasal Septal ButtonLFB · Traditional | Boston Medical Products, Inc. | 07/03/1997SE |
| K920994 | Hood Nasal Septal ButtonLFB · Traditional | Hood Laboratories | 05/15/1992SE |
| K901366 | Invotec Septal ButtonLFB · Traditional | Invotec International, Inc. | 06/14/1990SE |
| K871072 | Omega Nasal Septal ButtonLFB · Traditional | Omega Silicone, Inc. | 06/08/1987SE |
| K871200 | Cui Nasal Septum ButtonLFB · Traditional | Cox-Uphuff Intl. | 04/15/1987SE |
| K862497 | Microtek Septal ButtonLFB · Traditional | Microtek Medical, Inc. | 07/14/1986SE |
| K850492 | Nasal Septal ButtonLFB · Traditional | Santa Barbara Medco, Inc. | 03/07/1985SE |
| K822637 | Nasal Septal ButtonsLFB · Traditional | Abco Dealers, Inc. | 09/28/1982SE |
More from Abco Dealers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130736 | Blom-Singer Adjustable Bi-Fianged Fistula ProsthesisLRC · Traditional | 12/17/2013SE |
| 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 |
| K932163 | Blom-Singer Voice Prosthesis Flushing PipetEWL · Traditional | 12/15/1993SE |
| K930105 | Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S.EWL · Traditional | 05/17/1993SE |
Questions and answers
When was Blom-Singer Septal Perforation Prosthesis cleared by the FDA?
Blom-Singer Septal Perforation Prosthesis (K131745) received a 510(k) decision of Substantially Equivalent on September 17, 2013, 96 days after the submission was received.
What is the product code of K131745?
The FDA product code is LFB – Button, Nasal Septal, a Unclassified device.