OKO
- Product code
- OKO
- Device name
- Negative Pressure Wound Therapy Non-Powered Suction Apparatus
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4683
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 17 (all years; only the last 3 years are listed here)
FDA classification definition
A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251156 | 2025-05-15 | Guard Medical, Inc. | NPseal | |
| K250708 | 2025-04-08 | Guard Medical, Inc. | NPseal | |
| K241522 | 2024-08-15 | Guard Medical, Inc. | NPseal (20 and 25) | |
| K240244 | 2024-02-29 | Guard Medical, Inc. | NPseal (Small, Medium, Large) |
Official FDA classification page: OKO
Classification and pathway per current FDA publications. Data from openFDA (CC0).