ETHMOID SINUS SPACER
FDA 510(k) clearance K062458 · decided 2006-09-15
Clearance details
- K-number
- K062458
- Device name
- ETHMOID SINUS SPACER
- Applicant
- Acclarent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-23
- Decision date
- 2006-09-15
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- KAM
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rmenlo Park, 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 |
|---|---|---|
| RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) (K110687) | Acclarent, Inc. | 2011-10-07 |
| MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER (K093594) | Acclarent, Inc. | 2010-03-03 |
| RELIEVA STRATUS MICROFLOW SPACER (K083574) | Acclarent, Inc. | 2009-01-29 |
| SINUS SPACER (K072891) | Acclarent, Inc. | 2008-03-19 |
| RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (K073041) | Acclarent, Inc. | 2008-03-11 |
| RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A (K071845) | Acclarent, Inc. | 2007-09-28 |
| RELIENT NAVIGATION DEVICE (K060974) | Acclarent, Inc. | 2006-05-05 |
| MICROMEDICS SPHENOID SINUS STENT (K050340) | Micromedics, Inc. | 2005-04-27 |
| FRONTAL SINUS TREPHINATION CANNULA (K994262) | Xomed, Inc. | 2000-02-08 |
| XOMED T-STENT, FRONTAL SINUS STENT (K973273) | Xomed, Inc. | 1997-09-29 |
| ROSSITER SINUS STENT (K951803) | Smith & Nephew Richards, Inc. | 1995-05-11 |
| RAINS FRONTAL SINUS STENT (K951066) | Smith & Nephew Richards, Inc. | 1995-04-04 |
Recalls involving this device
No recalls on record reference this clearance.