TEKNA MED Myringotomy Dispos-Oto Kit

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

510(k) Number

K813616 ↗

FDA Product Code

ETD

Device Class

Class II

Regulation

21 CFR Part 874.3880

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Otological Ventilation Tubes

  Class II

  FDA 510(k) K802587 Active Cleared 12 Nov 1980

• Surgical Retractor & Elastic Stays, Disp

  Class I

  FDA 510(k) K812562 Active Cleared 2 Oct 1981

• Stainless Steel Pistons

  Class II

  FDA 510(k) K823483 Active Cleared 9 Dec 1982

• Drumto Stapes Prosthesis

  Class II

  FDA 510(k) K832540 Active Cleared 3 Jan 1984

• What is the TEKNA MED Myringotomy Dispos-Oto Kit primarily used for in surgical procedures?

  The TEKNA MED Myringotomy Dispos-Oto Kit is specifically designed for myringotomy and tympanostomy tube placement during otologic surgeries. It is part of the standard surgical management for middle ear conditions, such as recurrent ear infections or fluid buildup, where creating a small incision in the eardrum (myringotomy) and inserting a tube helps maintain drainage and ventilation.

• Is this kit intended for reuse, or is it meant to be used only once?

  The TEKNA MED Myringotomy Dispos-Oto Kit is explicitly labeled as a single-use device. It is supplied sterile and intended for disposal after one surgical procedure, ensuring patient safety and compliance with sterile field protocols.

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

  The kit should be stored in accordance with standard medical device handling practices, as outlined by the manufacturer, Humboldt Products. Since it is sterile and single-use, it must remain unopened and protected from contamination until immediately before use. Proper storage conditions—such as a clean, dry environment away from direct sunlight or extreme temperatures—are recommended to preserve its integrity.

• What regulatory pathway does this device follow, and when was it cleared?

  The TEKNA MED Myringotomy Dispos-Oto Kit is classified as a Class II device under product code ETD (Ear, Nose, and Throat) and is regulated under 21 CFR 874.3880. It received FDA 510(k) clearance under number K813616, with a decision of substantial equivalence dated January 22, 1982, following a traditional review process.

• Does this kit include all necessary components for a complete myringotomy procedure?

  While the exact contents of the kit are not detailed in the provided data, the TEKNA MED Myringotomy Dispos-Oto Kit is specifically designed as a complete tympanostomy tube system for myringotomy and tube placement. This implies it includes essential tools and materials required for the procedure, though clinicians should verify the included items in the packaging or manufacturer documentation to ensure compatibility with their surgical needs.