Elan-E Disposable Drape

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

510(k) Number

K884057 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Protegraft Dv 1500, 1900 & Low Por, Unigraft Dv

  Class II

  FDA 510(k) K890182 Active Cleared 28 Feb 1990

• Resurface Proshesis

  Not classified

  FDA 510(k) K781343 Active Cleared 27 Sep 1978

• Container System

  Class II

  FDA 510(k) K792558 Active Cleared 27 Dec 1979

• Drill, Dental

  Class I

  FDA 510(k) K801887 Active Cleared 20 Aug 1980

• Insitucat Valve Stripper

  Class II

  FDA 510(k) K885046 Active Cleared 28 Feb 1990

• Yasargil Aneurysm Clips

  Class II

  FDA 510(k) K772200 Active Cleared 8 Dec 1977

See all devices from Aesculap Instruments Corp. →

• What surgical procedures is the Elan-E Disposable Drape approved for?

  The Elan-E Disposable Drape is FDA-cleared for use in general, plastic, ophthalmic, urological, and otolaryngological surgical procedures. Its design ensures a sterile field while providing secure coverage, making it versatile for these specialties. The drape adheres to standard sterile field protocols in operating rooms.

• Is the Elan-E Drape reusable or single-use?

  The Elan-E Drape is explicitly designed for single-use only and must be discarded after one surgical procedure. This ensures patient safety and sterility, as reuse could compromise the integrity of the sterile barrier and introduce contamination risks.

• What configurations are available for the Elan-E Drape?

  The Elan-E Drape comes in a standard latex sheet design with a self-retaining finger cot. Optional configurations include an internal drape retention ring (wound protector) and a Kelly pad, which enhance secure coverage and protection during surgery. These features help maintain a sterile field while adapting to different procedural needs.

• How is the Elan-E Drape supplied, and what sterility guarantees are provided?

  The Elan-E Drape is supplied sterile and disposable, packaged for one-time use. It is manufactured under controlled conditions to ensure sterility before opening. Once opened, it must be used immediately and discarded after a single procedure to prevent contamination.

• Does the Elan-E Drape contain antimicrobial agents?

  No, the Elan-E Drape does not include antimicrobial agents in its formulation. Its sterility relies on manufacturing controls and single-use design rather than chemical additives. This aligns with standard surgical drape practices for maintaining a sterile field.