extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc

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

510(k) Number

K151240 ↗

FDA Product Code

OMP

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nature's Bond 600 and Nature's Bond 603

  Class II

  FDA 510(k) K142168 Active Cleared 4 Dec 2014

• Cirona 6400

  Class II

  FDA 510(k) K161209 Active Cleared 31 May 2016

• extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister

  Class II

  FDA 510(k) K143362 Active Cleared 3 Feb 2015

• Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System

  Class II

  FDA 510(k) K151189 Active Cleared 18 Sep 2015

• Extricare

  Class II

  FDA 510(k) K110078 Active Cleared 10 Feb 2012

• What is the extriCARE Negative Pressure Wound Therapy Gel Strip used for?

  The device is used for wound management by applying negative pressure to remove wound exudates, infectious materials, and tissue debris from the wound bed, facilitating wound healing as part of the extriCARE Negative Pressure Wound Therapy System.

• How is the extriCARE Negative Pressure Wound Therapy Gel Strip supplied?

  The device is supplied in multiple pack sizes: 8pc, 7pc, 6pc, 5pc, and 4pc configurations, allowing flexibility based on clinical needs and wound size.

• Is the extriCARE Negative Pressure Wound Therapy Gel Strip sterile and single-use?

  While the device data does not explicitly state sterility or single-use status, as a Class II medical device with FDA 510K clearance intended for wound therapy, it is designed for single-patient use to prevent cross-contamination and ensure safety during application.

• What regulatory pathway was used for the extriCARE Negative Pressure Wound Therapy Gel Strip?

  The device received FDA 510K clearance (K151240) and is classified as a Class II medical device under product code OMP, indicating it was found substantially equivalent to a legally marketed predicate device.

• What clinical specialties is the extriCARE Negative Pressure Wound Therapy Gel Strip intended for?

  The device is intended for use in general and plastic surgery applications, as indicated in both the device description and the FDA advisory committee designation for general and plastic surgery.