Sterile Stockinette

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760867 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Microscope Slides

  Class I

  FDA 510(k) K862112 Active Cleared 13 Jun 1986

• Sterile IV Set 4 Sizes

  Class II

  FDA 510(k) K832329 Active Cleared 24 Aug 1983

• Sterile, Foley Catheters W/Ptfe Coat

  Class II

  FDA 510(k) K841678 Active Cleared 19 Jul 1984

• Instrument Lubricant

  Not classified

  FDA 510(k) K780610 Active Cleared 31 May 1978

• Abco Mercurial Sphygmomanometer

  Class II

  FDA 510(k) K800236 Active Cleared 22 Feb 1980

• Abco Midstream Urine Collection Set

  Class I

  FDA 510(k) K800233 Active Cleared 26 Feb 1980

See all devices from Abco Dealers, Inc. →

• What is the purpose of Sterile Stockinette?

  Sterile Stockinette is designed to be applied over body parts to provide a protective covering and facilitate movement. It serves as a sterile barrier while allowing for comfortable movement of the covered area.

• How is Sterile Stockinette supplied and what is its intended use?

  The device is supplied in a sterile condition and is intended for single-use only. It comes in various sizes to accommodate different body parts and applications in medical settings.

• What is the regulatory classification of Sterile Stockinette?

  Sterile Stockinette is classified as a stocking, elastic product with product code KKX. It is regulated under FDA 510(k) clearance and was determined to be substantially equivalent to predicate devices.

• Can Sterile Stockinette be reused after application?

  No, Sterile Stockinette is intended for single-use only. After application, it should be discarded according to medical waste disposal protocols to maintain sterility and prevent cross-contamination.