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FDA 510(k)

Venturi Gauze Wound Care Sets with Portal Drain

K-Number: K151263 · 2016-02-19

ApplicantTalley Group, Ltd.
Decision Date2016-02-19
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venturi Gauze Wound Care Sets with Portal Drain is the device name listed in this FDA 510(k) record. The listed applicant is Talley Group, Ltd.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K151263. 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 Venturi Gauze Wound Care Sets with Portal Drain?

Venturi Gauze Wound Care Sets with Portal Drain is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Talley Group, Ltd.. The 510(k) number is K151263.

When did Venturi Gauze Wound Care Sets with Portal Drain receive FDA 510(k) clearance?

Venturi Gauze Wound Care Sets with Portal Drain received FDA 510(k) clearance on 2016-02-19, under 510(k) number K151263.

Who is the listed applicant for Venturi Gauze Wound Care Sets with Portal Drain?

The FDA 510(k) record lists Talley Group, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venturi Gauze Wound Care Sets with Portal Drain?

The FDA product code for Venturi Gauze Wound Care Sets with Portal Drain is OMP.

Other records listing Talley Group, Ltd. 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.

K143004VENTURI MiNO TG600/14

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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