FDA 510(k)

NEXA Negative Pressure Wound Therapy System

Numéro K : K162610 · 2017-06-08

Date de décision2017-06-08

Code produitOMP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

NEXA Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Medical , Ltd.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K162610. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the NEXA Negative Pressure Wound Therapy System?

NEXA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Nexa Medical , Ltd.. The 510(k) number is K162610.

When did NEXA Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

NEXA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-06-08, under 510(k) number K162610.

Who is the listed applicant for NEXA Negative Pressure Wound Therapy System?

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

What is the FDA product code for NEXA Negative Pressure Wound Therapy System?

The FDA product code for NEXA Negative Pressure Wound Therapy System is OMP.

Essais cliniques associés

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Dispositifs connexes (Code : OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

Source officielle

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