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Avance® Solo

FDA UDI

Class II (US FDA UDI)

by Mölnlycke Health Care AB

Identity

Trade Name
Avance® Solo FDA UDI
Generic Name
Negative-pressure wound therapy system, electric, single-use FDA UDI
Device Name
Avance Solo Pump and Canister Set FDA UDI
Model / Reference
8880050 FDA UDI
Description
Avance Solo Pump and Canister Set FDA UDI

Identifiers

Primary DI / UDI-DI
07323190296705 FDA UDI
510(k) Number
K203369 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system, electric, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system, electric, single-use

Avance® Solo by Mölnlycke Health Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system, electric, single-use.

Cleared under the same submission

K203369 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mölnlycke Health Care AB

Sources (1)

  • FDA UDI b0adb40b-41ea-4b36-a415-d3fd34320aeb 35 fields · synced Jun 8, 2026