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FDA 510(k)

UNO 30

K-Number: K190028 · 2020-01-15

ApplicantGenadyne Biotechnologies
Decision Date2020-01-15
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNO 30 is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K190028. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNO 30?

UNO 30 is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Genadyne Biotechnologies. The 510(k) number is K190028.

When did UNO 30 receive FDA 510(k) clearance?

UNO 30 received FDA 510(k) clearance on 2020-01-15, under 510(k) number K190028.

Who is the listed applicant for UNO 30?

The FDA 510(k) record lists Genadyne Biotechnologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNO 30?

The FDA product code for UNO 30 is OMP.

Other records listing Genadyne Biotechnologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253429Genadyne ASTRA NPWTK243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)K233614Genadyne DUO NPWTK221888Genadyne Hybrid Foam DressingsK221891UNO Negative Pressure Wound Therapy SystemK210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

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Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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