HADGEL, 4 GRAM/SYRINGE
FDA 510(k) clearance K011544 · decided 2001-08-15
Clearance details
- K-number
- K011544
- Device name
- HADGEL, 4 GRAM/SYRINGE
- Applicant
- Seikagaku Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-18
- Decision date
- 2001-08-15
- Days to decision
- 89 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
- Kitty Hawk, NC, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
|---|---|---|
| SUPARTZ FX; VISCO-3 (P980044/S065) | Seikagaku Corp. | 2025-12-19 |
| SUPARTZ FX (P980044/S064) | Seikagaku Corp. | 2025-08-18 |
| SUPARTZ FX; VISCO-3 (P980044/S063) | Seikagaku Corp. | 2025-07-22 |
| Gel-One (P080020/S054) | Seikagaku Corp. | 2025-06-18 |
| Gel-One (P080020/S053) | Seikagaku Corp. | 2025-01-17 |
| SUPARTZ FX, VISCO-3 (P980044/S062) | Seikagaku Corp. | 2024-07-25 |
| Gel-One (P080020/S052) | Seikagaku Corp. | 2023-12-08 |
| Gel-One (P080020/S051) | Seikagaku Corp. | 2023-01-05 |