StatSeal Disc
FDA 510(k) clearance K254073 · decided 2026-05-13
Clearance details
- K-number
- K254073
- Device name
- StatSeal Disc
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-18
- Decision date
- 2026-05-13
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Merit Medical Systems
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 |
|---|---|---|
| Microdacyn Wound Irrigation Solution (K261023) | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| SilverCeuticals® Antimicrobial Wound Gel (K251929) | Silverceuticals, Inc. | 2026-06-24 |
| Bonvadis® (K261638) | Oneness Biotech Co., Ltd. | 2026-06-17 |
| IWD-Gel™ (K254191) | InnovaCorium, Inc. | 2026-04-07 |
| MiraChlor Antimicrobial Wound Solution (K252023) | Letus Corporation | 2026-03-25 |
| Promogran Prisma™ Collagen Matrix with ORC and Silver (K251999) | Solventum Germany GmbH | 2026-03-13 |
| LUOFUCON® Antimicrobial Wound Gel (K252028) | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| Redermax Antibacterial Wound Matrix (K251582) | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| New Day Skin Spray (K252568) | Silk Holdings, Inc. | 2026-01-23 |
| SBC1 Cream (K250890) | Sioxmed, LLC | 2026-01-12 |
| revyve® Antimicrobial Skin and Wound Cleanser (K252759) | Kane Biotech, Inc. | 2026-01-08 |
| Puracyn® Plus Antimicrobial Irrigation Solution (K251757) | Innovacyn, Inc. | 2026-01-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |