KURZ CLIP PISTON MVP - 0.4 Mm + 1006 761-63

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

510(k) Number

K042503 ↗

FDA Product Code

ETA

Models / Variants

1006 711-13

0.4 Mm + 1006 761-63

0.6mm

Device Class

Class II

Regulation

21 CFR Part 874.3495

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Kurz Upper Eyelid Implant- Platinum/Iridium, Models Regular 4007 003-007, Special 4007 002, 4007 008-010

  Class II

  FDA 510(k) K011115 Active Cleared 2 May 2001

• Clip Piston Awengen, Model# 1006 805 - 1006 861

  Class II

  CE/MDD FDA 510(k) K021479 Active Cleared 21 May 2002

• Nitiflex Stapes Prosthesis

  Class II

  CE/MDD FDA 510(k) K130512 Active Cleared 2 Dec 2013

• Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire

  Class II

  CE/MDD FDA 510(k) K071150 Active Cleared 12 Dec 2007

• Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10

  Class II

  FDA 510(k) K000127 Active Cleared 12 Apr 2000

• Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T)

  Class II

  FDA 510(k) K973226 Active Cleared 4 Nov 1997

See all devices from Heinz Kurz GmbH Medizintechnik →

• What are the key differences between the 0.4 mm and 0.6 mm models of the Kurz Clip Piston MVP, and how do they address anatomical variations in patients?

  The Kurz Clip Piston MVP comes in two sizes—0.4 mm and 0.6 mm—to accommodate different anatomical requirements in the middle ear. The 0.4 mm model is designed for smaller ossicular gaps or patients with less space between the tympanic membrane and inner ear, while the 0.6 mm model provides a wider prosthesis for larger anatomical gaps. This variability ensures a secure fit and optimal sound transmission regardless of the patient’s specific ossicular chain discontinuity.

• How should the Kurz Clip Piston MVP be prepared and handled before surgical implantation to ensure sterility?

  The Kurz Clip Piston MVP is intended for reusable surgical use but must be handled under sterile conditions prior to implantation. It should be sterilized according to standard medical device protocols and only used with sterile instruments during the procedure to prevent contamination. The device is not pre-sterilized in its packaging, so proper sterilization and aseptic technique are critical before use.

• Are there any specific storage requirements for the Kurz Clip Piston MVP, and how should it be preserved between uses?

  Since the Kurz Clip Piston MVP is a reusable implant, it must be stored in a clean, dry environment to prevent damage or contamination between uses. After sterilization, it should be kept in a sealed, sterile packaging or container until ready for surgical use. The manufacturer’s instructions for sterilization and storage should be followed to maintain its integrity and functionality.

• What regulatory pathways does the Kurz Clip Piston MVP follow, and which advisory committee oversees its classification?

  The Kurz Clip Piston MVP follows the FDA’s 510(k) Traditional pathway and is classified as Substantially Equivalent (SESE) under the Ear, Nose, and Throat (ENT) specialty. It was reviewed by the Ear, Nose, and Throat (EN) Advisory Committee and is also compliant with the Medical Device Directive (MDD) in Europe. The device’s classification as Class II under FDA regulations reflects its role as a critical implant for restoring conductive hearing loss.