Blom-Singer Tracheoesophageal Puncture Set

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

510(k) Number

K920090 ↗

FDA Product Code

EWL

Device Class

Class II

Regulation

21 CFR Part 874.3730

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Blom-Singer Septal Perforation Prosthesis

  Unclassified

  FDA 510(k) K131745 Active Cleared 17 Sep 2013

• Inhealth Blom-Singer Indwelling Plug Insert Accessory Device

  Class II

  FDA 510(k) K945288 Active Cleared 2 Dec 1994

• Blom-Singer Indwelling 2000 Voice Prosthesis

  Class II

  FDA 510(k) K991587 Active Cleared 25 Jun 1999

• Blom-Singer Shower Guard

  Class II

  FDA 510(k) K904729 Active Cleared 28 Feb 1991

• Blom-Singer Humid/Fil Syst Inhealth in-Line Humid.

  Class I

  FDA 510(k) K915786 Active Cleared 30 Jun 1992

• Blom-Singer Indwelling Tep Occluder

  Class II

  FDA 510(k) K093258 Active Cleared 3 Mar 2010

See all devices from Helix Medical, Inc. →

• What is the Blom-Singer Tracheoesophageal Puncture Set used for?

  This set is designed specifically for creating a controlled puncture in the tracheoesophageal septum during surgery. The procedure enables subsequent placement of a valved voice prosthesis, restoring speech function in patients who have undergone a laryngectomy. It is intended for professional medical use in the Ear, Nose, and Throat (ENT) specialty.

• Is the Blom-Singer Tracheoesophageal Puncture Set sterile and single-use?

  Yes, the device is supplied sterile and is intended for single-use only. Sterility and single-use are critical for maintaining procedural integrity and preventing infection, especially in sensitive surgical procedures like tracheoesophageal puncture.

• What components are included in the Blom-Singer Tracheoesophageal Puncture Set?

  The set is supplied as a complete kit, containing all necessary components required to perform the puncture procedure. While the exact components are not detailed here, it is designed to provide everything needed for a controlled tracheoesophageal puncture in a sterile environment.

• How should the Blom-Singer Tracheoesophageal Puncture Set be stored?

  The set must be stored and handled according to sterile medical instrument protocols. This ensures the integrity of the device and reduces the risk of contamination before use. Improper storage could compromise sterility and procedural safety.

• What regulatory clearance does the Blom-Singer Tracheoesophageal Puncture Set have?

  The device holds FDA 510(k) clearance under the classification of Prosthesis, Laryngeal (Taub), with the clearance number K920090. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets applicable regulatory requirements for safety and effectiveness.