MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
Device Facts
| Record ID | K962688 |
|---|---|
| Device Name | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE |
| Applicant | Boston Medical Products, Inc. |
| Product Code | KCF · Ear, Nose, Throat |
| Decision Date | Jul 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4420 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
1. Treatment of pharyngocutaneous fistulas following laryngectomy or laryngoesophagectomy. 2. Management of cervical esophageal and hypopharyngeal strictures and fistulas resulting from a variety of causes including surgery, radiation, advanced malignancy, trauma, and ingestion of caustic agents.
Device Story
Silicone tube with funnel-shaped end; used for esophageal strictures and fistulas. Inserted by clinicians to bypass damaged areas. Provides mechanical support/conduit for saliva/food passage. Available in 8mm-20mm diameters. Radiopaque for visualization.
Clinical Evidence
Bench testing only. Finished device samples passed cytotoxicity testing (Elution Test, USP 23) and were determined to be non-reactive and non-cytotoxic.
Technological Characteristics
Silicone tube with funnel-shaped end; radiopaque. Available in 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, and 20mm outside diameters. Biocompatibility verified via USP 23 Elution Test.
Indications for Use
Indicated for patients with pharyngocutaneous fistulas post-laryngectomy/laryngoesophagectomy or cervical esophageal/hypopharyngeal strictures/fistulas caused by surgery, radiation, malignancy, trauma, or caustic ingestion.
Regulatory Classification
Identification
An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.
Predicate Devices
- Montgomery Salivary Bypass Tube
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