GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
FDA 510(k) clearance K080022 · decided 2008-12-09
Clearance details
- K-number
- K080022
- Device name
- GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
- Applicant
- Vascular Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-03
- Decision date
- 2008-12-09
- Days to decision
- 341 days
- Clearance type
- Traditional
- Product code
- KHJ
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Minneapolis, MN, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Duett Sealing Device (D-Stat Flowable) (P990037/S036) | Vascular Solutions, Inc. | 2022-11-04 |
| Duett Sealing Device (P990037/S035) | Vascular Solutions, Inc. | 2021-07-13 |
| D-Stat Flowable hemostat (P990037/S034) | Vascular Solutions, Inc. | 2016-10-05 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S032) | Vascular Solutions, Inc. | 2016-02-25 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S031) | Vascular Solutions, Inc. | 2010-09-15 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S030) | Vascular Solutions, Inc. | 2010-05-07 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S029) | Vascular Solutions, Inc. | 2009-12-02 |
| DUETT PRO SEALING DEVICE, MODEL 1010 (P990037/S028) | Vascular Solutions, Inc. | 2008-12-17 |