Button, Nasal Septal
A nasal septal button is a device inserted into a perforation of the nasal septum to occlude the opening and restore the structural integrity of the septum, often used in patients with septal perforations caused by trauma, surgery, or disease. This device is currently unclassified by the FDA, meaning it has not been placed into a formal device class through the standard classification procedure. It carries product code LFB and no regulation number or medical specialty has been assigned. This device is flagged as an implant, indicating it is placed into the body.
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Basic Information
- Product Code
- LFB
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131745 | BLOM-SINGER SEPTAL PERFORATION PROSTHESIS | Sep 17, 2013 | Substantially Equivalent | Helix Medical, LLC |
| K013696 | SILMED NASAL SEPTAL BUTTON | Nov 28, 2001 | Substantially Equivalent | Silmed, Inc. |
| K982667 | MICROMEDICS NASAL SEPTAL BUTTON | Nov 24, 1998 | Substantially Equivalent | Micromedics, Inc. |
| K972060 | NASAL SEPTAL BUTTON | Jul 03, 1997 | Substantially Equivalent | Boston Medical Products, Inc. |
| K920994 | HOOD NASAL SEPTAL BUTTON | May 15, 1992 | Substantially Equivalent | Hood Laboratories |
| K901366 | INVOTEC SEPTAL BUTTON | Jun 14, 1990 | Substantially Equivalent | Invotec International, Inc. |
| K871072 | OMEGA NASAL SEPTAL BUTTON | Jun 08, 1987 | Substantially Equivalent | Omega Silicone, Inc. |
| K871200 | CUI NASAL SEPTUM BUTTON | Apr 15, 1987 | Substantially Equivalent | Cox-Uphuff Intl. |
| K862497 | MICROTEK SEPTAL BUTTON | Jul 14, 1986 | Substantially Equivalent | Microtek Medical, Inc. |
| K850492 | NASAL SEPTAL BUTTON | Mar 07, 1985 | Substantially Equivalent | Santa Barbara Medco, Inc. |
| K822637 | NASAL SEPTAL BUTTONS | Sep 28, 1982 | Substantially Equivalent | Abco Dealers, Inc. |
| K781529 | SEPTAL BUTTON | Oct 17, 1978 | Substantially Equivalent | Xomed, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.