Identifiers
- 510(k) Number
- K212971 FDA 510(k)
- FDA Product Code
- OKO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4683 FDA 510(k)
- Regulation Number
- 878.4683 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
NPseal is a Negative Pressure Wound Therapy Non-Powered Suction Apparatus used for wound management. It provides non-powered suction therapy to promote wound healing through negative pressure application.
The device is supplied for use in General and Plastic Surgery settings. NPseal is a Class II medical device with FDA 510K clearance. It is manufactured by Guard Medical, Inc. and is available in various sizes as specified by the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212971 | Class II | Active |
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Manufacturer
- Manufacturer
- Guard Medical, Inc.
Sources (1)
- FDA 510(k) K212971 24 fields · synced Oct 6, 2026