SEPRAGEL SINUS
FDA 510(k) clearance K012532 · decided 2001-10-30
Clearance details
- K-number
- K012532
- Device name
- SEPRAGEL SINUS
- Applicant
- Genzyme Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-06
- Decision date
- 2001-10-30
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LYA
- Device class
- 1
- Regulation number
- 874.4780
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Ridgefield, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Genzyme Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TurbAlign (K243655) | Spirair, Inc. | 2025-07-11 |
| Epi-Stop Nasal Gel/epistaxis pack (K230142) | Biomed Ent, Inc. | 2023-03-22 |
| SPIWay Endonasal Access Guide (K213153) | Spiway, LLC | 2021-10-27 |
| Novapak Nasal Sinus Packing and Stent (K202623) | Medtronic Xomed | 2020-12-08 |
| ChitoZolve (K181696) | Gyrus Acmi, Inc. | 2018-11-30 |
| SPIWay Endonasal Access Guide (K180141) | Spiway, LLC | 2018-02-16 |
| Composite Removable Sinus Stent System (K170913) | Sts Medical | 2017-12-15 |
| Chitogel Endoscopic Sinus Surgery Kit (K172179) | Chitogel, Ltd. | 2017-10-17 |
| SPIWay Endonasal Access Guide (K153686) | Spiway, LLC | 2016-01-28 |
| HEMOPORE (K141816) | Polyganics B.V., | 2014-10-23 |
| NOVASHIELD INJECTABLE NASAL PACKING AND STENT (K141704) | Medtronic, Inc. | 2014-10-06 |
| NASOPORE-FD (K141423) | Polyganics B.V., | 2014-08-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGOO (P110003/S004) | Genzyme Corp. | 2014-03-26 |
| LEGOO (P110003/S003) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUSION GEL (P110003/S002) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUDER (P110003/S001) | Genzyme Corp. | 2012-03-01 |
| LEGOO (P110003) | Genzyme Corp. | 2011-09-28 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S007) | Genzyme Corp. | 2003-12-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S006) | Genzyme Corp. | 2003-02-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S005) | Genzyme Corp. | 2002-11-25 |