FDA 510(k) Applications for Medical Device Product Code "OKO"
| FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
| K193185 |
BenQ Materials Corporation |
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System |
05/04/2020 |
| K212971 |
Guard Medical Inc |
NPseal |
02/10/2022 |
| K200305 |
Guard Medical Inc. |
NPseal |
05/26/2020 |
| K211130 |
Guard Medical Inc. |
NPseal |
05/14/2021 |
| K240244 |
Guard Medical Inc. |
NPseal (Small, Medium, Large) |
02/29/2024 |
| K250708 |
Guard Medical, Inc. |
NPseal |
04/08/2025 |
| K251156 |
Guard Medical, Inc. |
NPseal |
05/15/2025 |
| K241522 |
Guard Medical, Inc. |
NPseal (20 and 25) |
08/15/2024 |
| K111006 |
SPIRACUR, INC. |
CI-SNAP WOUND CARE SYSTEM |
07/21/2011 |
| K133137 |
SPIRACUR, INC. |
CISNAP CLOSED INCISION SYSTEM |
02/25/2014 |
| K111393 |
SPIRACUR, INC. |
SNAP (R) WOUND CARE SYSTEM |
07/28/2011 |
| DEN080011 |
SPIRACUR, INC. |
SNAP WOUND CARE DEVICE |
08/07/2009 |
| K142272 |
SPIRACUR, INC. |
SNaP Wound Care System |
11/25/2014 |
| K151710 |
SPIRACUR, INC. |
SNaP Wound Care System |
11/19/2015 |
| K112341 |
SPIRACUR, INC. |
SNAP WOUND CARE SYSTEM |
08/29/2011 |
| K113032 |
SPIRACUR, INC. |
SNAP WOUND CARE SYSTEM |
12/01/2011 |
| K132080 |
SPIRACUR, INC. |
SNAP WOUND CARE SYSTEM |
03/12/2014 |
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