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510(k) K203369

Device
Avance Solo Negative Pressure Wound Therapy (NPWT) System
Applicant
Molnlycke Health Care US, LLC
510(k) number
K203369
Product code
OMP  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-01
Date received
2020-11-16
Regulation
878.4780
Classification name
Negative Pressure Wound Therapy Powered Suction Pump
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Megan Bevill
Address
5445 Triangle Pkwy. Suite 400 Peachtree Corners GA US 30092 30092

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OMP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.2026-05-27
K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical2026-05-21
K254019Wound Geni NPWT SystemBechtel Medical, Inc.2026-05-04
K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.2026-03-12
K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryDeroyal Industries, Inc.2025-11-21
K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices2025-10-03
K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.2025-09-11
K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical2025-06-27
K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft PortSmith & Nephew Medical, Ltd.2025-02-18
K233614Genadyne DUO NPWTGenadyne Biotechnologies, Inc.2024-12-23
K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical2024-08-21
K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.2024-08-19
K241515NEXA™ NPWT SystemNexa Medical Limited2024-07-26
K231939Renasys EdgeSmith & Nephew Medical, Ltd.2024-05-24
K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc.2024-05-23

Legacy Summary#

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FDA Review#

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