← Product Code [OKO](/productcode/OKO) · K254160

# VacHeal Negative Pressure Wound Therapy System (K254160)

_VacHeal, LLC · OKO · Sep 18, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K254160

## Device Facts

- **Applicant:** VacHeal, LLC
- **Product Code:** [OKO](/productcode/OKO.md)
- **Decision Date:** Sep 18, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4683
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/device/K254160](https://fda.innolitics.com/device/K254160)

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