Circulon System Step 2

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

510(k) Number

K951021 ↗

FDA Product Code

MCY

Device Class

Class II

Regulation

21 CFR Part 880.5075

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• Duoderm(R) Adhesive Compression Bandage, Modified

  Class I

  FDA 510(k) K912550 Active Cleared 14 Aug 1991

• Duoderm Dressings, Cgf Dressings, Paste Full Thick

  Unclassified

  FDA 510(k) K904852 Active Cleared 25 Jan 1991

• Stomahesive Skin Barrier Sterile

  Class I

  FDA 510(k) K851840 Active Cleared 24 Jun 1985

• Allkare Barrier Wipe

  Class I

  FDA 510(k) K925004 Active Cleared 12 Jan 1994

• Duoderm* Extra Thin Flexible Hydrocolloid Dressing

  Class I

  FDA 510(k) K891696 Active Cleared 4 May 1989

• Nonwoven Pad

  Class I

  FDA 510(k) K980720 Active Cleared 15 Apr 1998

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• What is the Circulon System Step 2 used for?

  The Circulon System Step 2 is a wound dressing kit specifically designed to facilitate the management and care of wounds within general hospital settings.

• Is this device regulated by the FDA?

  Yes, the Circulon System Step 2 is subject to FDA 510(k) clearance. It is classified under regulation number 880.5075 for use in general hospital environments.

• What is the regulatory classification of this kit?

  The device is classified as a Class 2 medical device under regulation number 880.5075, which pertains to wound dressing kits used in general hospital settings.