Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K013573 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

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 is the Clip Partial Prosthesis Titanium Dresden primarily used for in surgical procedures?

  The Clip Partial Prosthesis Titanium Dresden is designed specifically for tympanoplasty procedures to reconstruct gaps in the ossicular chain. It bridges these gaps, particularly after trauma, disease, or surgical removal of ossicles, helping to restore middle ear function by securely attaching to the stapes head via its spring-loaded mechanism.

• Is this device reusable, or is it intended for single-use only?

  The Clip Partial Prosthesis Titanium Dresden is explicitly intended for single-use applications in otologic surgery. This classification ensures sterility and safety, requiring adherence to sterile handling techniques during use.

• How should this device be stored to maintain its sterility and functionality?

  The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, proper storage conditions are critical to prevent contamination and ensure it remains ready for use in sterile surgical environments.

• What regulatory pathways does this device follow, and which committees oversee its approval?

  The Clip Partial Prosthesis Titanium Dresden follows the FDA’s 510(k) clearance process and complies with the Medical Device Directive (MDD). Its regulatory oversight includes the Ear, Nose, and Throat (ENT) advisory committee, as indicated by the submission details.

• What material is the prosthesis made of, and why is this significant?

  The prosthesis is constructed from titanium, which provides durability and biocompatibility. This material choice ensures it is well-tolerated by the body and capable of withstanding the mechanical demands of middle ear function over time.