BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
FDA 510(k) clearance K131745 · decided 2013-09-17
Clearance details
- K-number
- K131745
- Device name
- BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
- Applicant
- Helix Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-06-13
- Decision date
- 2013-09-17
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- LFB
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SILMED NASAL SEPTAL BUTTON (K013696) | Silmed, Inc. | 2001-11-28 |
| MICROMEDICS NASAL SEPTAL BUTTON (K982667) | Micromedics, Inc. | 1998-11-24 |
| NASAL SEPTAL BUTTON (K972060) | Boston Medical Products, Inc. | 1997-07-03 |
| HOOD NASAL SEPTAL BUTTON (K920994) | Hood Laboratories | 1992-05-15 |
| INVOTEC SEPTAL BUTTON (K901366) | Invotec International, Inc. | 1990-06-14 |
| OMEGA NASAL SEPTAL BUTTON (K871072) | Omega Silicone, Inc. | 1987-06-08 |
| CUI NASAL SEPTUM BUTTON (K871200) | Cox-Uphuff Intl. | 1987-04-15 |
| MICROTEK SEPTAL BUTTON (K862497) | Microtek Medical, Inc. | 1986-07-14 |
| NASAL SEPTAL BUTTON (K850492) | Santa Barbara Medco, Inc. | 1985-03-07 |
| NASAL SEPTAL BUTTONS (K822637) | Abco Dealers, Inc. | 1982-09-28 |
| SEPTAL BUTTON (K781529) | Xomed, Inc. | 1978-10-17 |
Recalls involving this device
No recalls on record reference this clearance.