Negative Pressure Wound Therapy Non-Powered Suction Apparatus
The Negative Pressure Wound Therapy Non-Powered Suction Apparatus (product code OKO) is a Class 2 device regulated under 21 CFR 878.4683 in the General, Plastic Surgery specialty (SU), cleared through the 510(k) pathway. It is a non-powered suction apparatus indicated for wound management by applying continual or intermittent negative pressure to remove fluids including wound exudate, irrigation fluids, and infectious materials. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OKO
- Device Class
- FDA class 2
- Regulation Number
- 878.4683
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251156 | NPseal | May 15, 2025 | Substantially Equivalent | Guard Medical, Inc. |
| K250708 | NPseal | Apr 08, 2025 | Substantially Equivalent | Guard Medical, Inc. |
| K241522 | NPseal (20 and 25) | Aug 15, 2024 | Substantially Equivalent | Guard Medical, Inc. |
| K240244 | NPseal (Small, Medium, Large) | Feb 29, 2024 | Substantially Equivalent | Guard Medical, Inc. |
| K212971 | NPseal | Feb 10, 2022 | Substantially Equivalent | Guard Medical, Inc. |
| K211130 | NPseal | May 14, 2021 | Substantially Equivalent | Guard Medical, Inc. |
| K200305 | NPseal | May 26, 2020 | Substantially Equivalent | Guard Medical, Inc. |
| K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System | May 04, 2020 | Substantially Equivalent | Benq Materials Corporation |
| K151710 | SNaP Wound Care System | Nov 19, 2015 | Substantially Equivalent | Spiracur, Inc. |
| K142272 | SNaP Wound Care System | Nov 25, 2014 | Substantially Equivalent | Spiracur, Inc. |
| K132080 | SNAP WOUND CARE SYSTEM | Mar 12, 2014 | Substantially Equivalent | Spiracur, Inc. |
| K133137 | CISNAP CLOSED INCISION SYSTEM | Feb 25, 2014 | Substantially Equivalent | Spiracur, Inc. |
| K113032 | SNAP WOUND CARE SYSTEM | Dec 01, 2011 | Substantially Equivalent | Spiracur, Inc. |
| K112341 | SNAP WOUND CARE SYSTEM | Aug 29, 2011 | Substantially Equivalent | Spiracur, Inc. |
| K111393 | SNAP (R) WOUND CARE SYSTEM | Jul 28, 2011 | Substantially Equivalent | Spiracur, Inc. |
| K111006 | CI-SNAP WOUND CARE SYSTEM | Jul 21, 2011 | Substantially Equivalent | Spiracur, Inc. |
| DEN080011 | SNAP WOUND CARE DEVICE | Aug 07, 2009 | Unknown | Spiracur, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.