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FDA 510(k)

Genadyne Hybrid Foam Dressings

K-Number: K221888 · 2023-06-12

ApplicantGenadyne Biotechnologies, Inc.
Decision Date2023-06-12
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Genadyne Hybrid Foam Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K221888. 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 Genadyne Hybrid Foam Dressings?

Genadyne Hybrid Foam Dressings is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K221888.

When did Genadyne Hybrid Foam Dressings receive FDA 510(k) clearance?

Genadyne Hybrid Foam Dressings received FDA 510(k) clearance on 2023-06-12, under 510(k) number K221888.

Who is the listed applicant for Genadyne Hybrid Foam Dressings?

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

What is the FDA product code for Genadyne Hybrid Foam Dressings?

The FDA product code for Genadyne Hybrid Foam Dressings is OMP.

Other records listing Genadyne Biotechnologies, Inc. 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 NPWTK221891UNO Negative Pressure Wound Therapy SystemK210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemK190028UNO 30

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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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