← Product Code [KCF](/submissions/EN/subpart-e%E2%80%94surgical-devices/KCF) · K962688

# MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE (K962688)

_Boston Medical Products, Inc. · KCF · Jul 25, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KCF/K962688

## Device Facts

- **Applicant:** Boston Medical Products, Inc.
- **Product Code:** [KCF](/submissions/EN/subpart-e%E2%80%94surgical-devices/KCF.md)
- **Decision Date:** Jul 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4420
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **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.

## Regulatory 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

## Submission Summary (Full Text)

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JUL 25 1996
K962688

# SMDA Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

**Product:** Montgomery Radiopaque Salivary Bypass Tube

**Description:** The Montgomery Salivary Bypass Tube is a silicone tube with a funnel-shaped end for use in treating esophageal strictures and fistulas. The tube is available is sizes 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, and 20mm (outside diameter).

**Indication For 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.

**Predicate Device:** Montgomery Salivary Bypass Tube.

**Testing:** Finished device samples passed cytotoxicity testing and were determined to be non-reactive and non-cytotoxic based on Elution Test, USP 23.

Submitted by: Stuart K. Montgomery, President

Date: 7/10/96

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KCF/K962688](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KCF/K962688)

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