Device Dossier
Prosthesis, internal, valve, speech, tracheostomy
Device Dossier for Prosthesis, internal, valve, speech, tracheostomy (Prosthesis, internal, valve, speech, tracheostomy, Class IIb, sponsor…
- GMDN category: Prosthesis, internal, valve, speech, tracheostomy
- Sponsor: Endotherapeutics
Intended purpose
The Blom-Singer FirstFit Surgical Kit (FFSK) is indicated for use during surgical creation of primary or secondary tracheoesophageal puncture, dilation of the tracheoesophageal wall, and to guide the placement of the voice prosthesis for tracheoesophageal voice restoration following total laryngectomy. The FFSK contains a sterile single-use Blom-Singer Indwelling Voice Prosthesis device intended for voice rehabilitation after surgical removal of the larynx (laryngectomy).