Avance Tubing, Avance Y-Connector, Avance ViewPad

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K161797 ↗

FDA Product Code

OMP

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Avance Gauze Dressing Kits

  Class II

  FDA 510(k) K161948 Active Cleared 3 Nov 2016

• Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro

  Class I

  FDA 510(k) K193573 Active Cleared 10 Apr 2020

• Biogel Orthopor Brown Surgical Glove

  Class I

  FDA 510(k) K112089 Active Cleared 24 Aug 2011

• Exufiber Ag+

  Unclassified

  FDA 510(k) K160379 Active Cleared 25 Aug 2016

• Biogel (R) Indicator (R) Underglove

  Class I

  FDA 510(k) K111413 Active Cleared 30 Jan 2012

• Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

  Class I

  FDA 510(k) K191869 Active Cleared 13 Mar 2020

See all devices from Molnlycke Health Care Us, LLC →

• What is the Avance Tubing, Y-Connector, and ViewPad used for?

  These components are part of a negative pressure wound therapy system: the tubing connects the pump to wound dressings, the Y-connector allows multiple dressings to connect to a single pump, and the ViewPad interfaces with the wound cover to transport exudate from the wound to the pump.

• Are the Avance Tubing, Y-Connector, and ViewPad supplied sterile or non-sterile?

  The device data does not specify whether these components are supplied sterile or non-sterile; therefore, sterility status cannot be determined from the provided information.

• Is the Avance Tubing, Y-Connector, and ViewPad intended for single-use or reuse?

  The device data does not indicate whether these components are designed for single-use or reuse, so no determination can be made about their reusability based on the available information.

• What regulatory pathway was used for the Avance Tubing, Y-Connector, and ViewPad?

  These components received FDA 510(k) clearance under submission K161797, which is a traditional 510(k) pathway for demonstrating substantial equivalence to a legally marketed device.

• What is the device class and regulation number for the Avance Tubing, Y-Connector, and ViewPad?

  The Avance Tubing, Y-Connector, and ViewPad are classified as class II medical devices under regulation number 878.4780, as specified in their FDA 510(k) clearance documentation.