Panels › General, Plastic Surgery › Product code OKO · Class 2
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Regulation 878.4683
1510(k)s in 12 months (18 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OKO
| Company | 510(k)s | Recalls |
|---|---|---|
| Spiracur, Inc. | 9 | 0 |
| Guard Medical, Inc. | 7 | 0 |
| Benq Materials Corporation | 1 | 0 |
| VacHeal, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2026 | K254160 | VacHeal Negative Pressure Wound Therapy System VacHeal, LLC | OKO |
| May 15, 2025 | K251156 | NPseal Guard Medical, Inc. | OKO |
| Apr 8, 2025 | K250708 | NPseal Guard Medical, Inc. | OKO |
| Aug 15, 2024 | K241522 | NPseal (20 and 25) Guard Medical, Inc. | OKO |
| Feb 29, 2024 | K240244 | NPseal (Small, Medium, Large) Guard Medical, Inc. | OKO |
| Feb 10, 2022 | K212971 | NPseal Guard Medical, Inc. | OKO |
| May 14, 2021 | K211130 | NPseal Guard Medical, Inc. | OKO |
| May 26, 2020 | K200305 | NPseal Guard Medical, Inc. | OKO |
| May 4, 2020 | K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System Benq Materials Corporation, TW | OKO |
| Nov 19, 2015 | K151710 | SNaP Wound Care System Spiracur, Inc. | OKO |
| Nov 25, 2014 | K142272 | SNaP Wound Care System Spiracur, Inc. | OKO |
| Mar 12, 2014 | K132080 | SNAP WOUND CARE SYSTEM Spiracur, Inc. | OKO |
| Feb 25, 2014 | K133137 | CISNAP CLOSED INCISION SYSTEM Spiracur, Inc. | OKO |
| Dec 1, 2011 | K113032 | SNAP WOUND CARE SYSTEM Spiracur, Inc. | OKO |
| Aug 29, 2011 | K112341 | SNAP WOUND CARE SYSTEM Spiracur, Inc. | OKO |
| Jul 28, 2011 | K111393 | SNAP (R) WOUND CARE SYSTEM Spiracur, Inc. | OKO |
| Jul 21, 2011 | K111006 | CI-SNAP WOUND CARE SYSTEM Spiracur, Inc. | OKO |
| Aug 7, 2009 | DEN080011 | SNAP WOUND CARE DEVICE Spiracur, Inc. | OKO |
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