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FDA 510(k)

EXTRICARE NPWT FOOT DRESSING

K-Number: K131464 · 2013-08-13

ApplicantDevon Medical, Inc.
Decision Date2013-08-13
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXTRICARE NPWT FOOT DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Devon Medical, Inc.. It received FDA 510(k) clearance on 2013-08-13 under 510(k) number K131464. 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 EXTRICARE NPWT FOOT DRESSING?

EXTRICARE NPWT FOOT DRESSING is a medical device that received FDA 510(k) clearance on 2013-08-13. The listed applicant is Devon Medical, Inc.. The 510(k) number is K131464.

When did EXTRICARE NPWT FOOT DRESSING receive FDA 510(k) clearance?

EXTRICARE NPWT FOOT DRESSING received FDA 510(k) clearance on 2013-08-13, under 510(k) number K131464.

Who is the listed applicant for EXTRICARE NPWT FOOT DRESSING?

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

What is the FDA product code for EXTRICARE NPWT FOOT DRESSING?

The FDA product code for EXTRICARE NPWT FOOT DRESSING is OMP.

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Other records listing Devon Medical, 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.

K131743CIRONA DVT FOOT GARMENTK130571DEVON CIRONA 6100 DVTK123959CIRCUFLOW 5150K123647CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICEK102582ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICEK101523CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE

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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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.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.

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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