OKO · Negative Pressure Wound Therapy Non-Powered Suction Apparatus
General, Plastic Surgery · 21 CFR 878.4683 · Class 2
Overview
| Product Code | OKO |
|---|---|
| Device Name | Negative Pressure Wound Therapy Non-Powered Suction Apparatus |
| Regulation | 21 CFR 878.4683 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251156 | NPseal | Guard Medical, Inc. | May 15, 2025 | SESE |
| K250708 | NPseal | Guard Medical, Inc. | Apr 8, 2025 | SESE |
| K241522 | NPseal (20 and 25) | Guard Medical, Inc. | Aug 15, 2024 | SESE |
| K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | Feb 29, 2024 | SESE |
| K212971 | NPseal | Guard Medical, Inc. | Feb 10, 2022 | SESE |
| K211130 | NPseal | Guard Medical, Inc. | May 14, 2021 | SESE |
| K200305 | NPseal | Guard Medical, Inc. | May 26, 2020 | SESE |
| K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System | Benq Materials Corporation | May 4, 2020 | SESE |
| K151710 | SNaP Wound Care System | Spiracur, Inc. | Nov 19, 2015 | SESE |
| K142272 | SNaP Wound Care System | Spiracur, Inc. | Nov 25, 2014 | SESE |
| K132080 | SNAP WOUND CARE SYSTEM | Spiracur, Inc. | Mar 12, 2014 | SESE |
| K133137 | CISNAP CLOSED INCISION SYSTEM | Spiracur, Inc. | Feb 25, 2014 | SESE |
| K113032 | SNAP WOUND CARE SYSTEM | Spiracur, Inc. | Dec 1, 2011 | SESE |
| K112341 | SNAP WOUND CARE SYSTEM | Spiracur, Inc. | Aug 29, 2011 | SESE |
| K111393 | SNAP (R) WOUND CARE SYSTEM | Spiracur, Inc. | Jul 28, 2011 | SESE |
| K111006 | CI-SNAP WOUND CARE SYSTEM | Spiracur, Inc. | Jul 21, 2011 | SESE |
| DEN080011 | SNAP WOUND CARE DEVICE | Spiracur, Inc. | Aug 7, 2009 | DENG |
Top Applicants
- Spiracur, Inc. — 9 clearances
- Guard Medical, Inc. — 7 clearances
- Benq Materials Corporation — 1 clearance
