Clip Piston Awengen, Model# 1006 805 - 1006 861

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K021479 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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See all devices from Heinz Kurz GmbH Medizintechnik →

• What is the Clip Piston Awengen primarily used for in surgical procedures?

  The Clip Piston Awengen is designed as a partial ossicular replacement prosthesis to restore conductive hearing in patients with middle ear ossicular chain disruptions. It bridges the gap between the tympanic membrane and the inner ear, facilitating sound transmission where natural ossicles are damaged or absent.

• How many sizes are available for the Clip Piston Awengen, and why does this matter?

  The Clip Piston Awengen comes in multiple sizes (models 1006 805 through 1006 861) to accommodate varying anatomical requirements. This ensures surgeons can select the appropriate implant size for the patient’s specific ear anatomy, improving fit and functional outcomes during ossicular reconstruction.

• Is the Clip Piston Awengen reusable, or is it intended for single-use only?

  The Clip Piston Awengen is explicitly intended for single-use in otologic surgical procedures. It is supplied sterile and pre-packaged, which aligns with best practices for implantable medical devices to minimize infection risks and ensure patient safety.

• Can this device be used in MRI environments, and if so, under what conditions?

  Yes, the Clip Piston Awengen is compatible with MRI environments under specified conditions. While the exact parameters aren’t detailed here, this compatibility is important for patients who may require future MRI scans, as it avoids the need for removal or alternative implants.

• What regulatory pathways does the Clip Piston Awengen follow in the U.S. and Europe?

  In the U.S., the Clip Piston Awengen is authorized under FDA 510(k) clearance (K021479) and classified as a Class II device. It is also compliant with the EU Medical Device Directive (MDD), ensuring it meets both U.S. and European regulatory standards for ossicular reconstruction implants.