← Product Code [OMP](/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP) · K210107

# Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (K210107)

_Genadyne Biotechnologies, Inc. · OMP · Jun 1, 2022 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K210107

## Device Facts

- **Applicant:** Genadyne Biotechnologies, Inc.
- **Product Code:** [OMP](/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP.md)
- **Decision Date:** Jun 1, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4780
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K210107](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K210107)

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