Dilator, Esophageal, Ent
An esophageal dilator for ENT use is an instrument used to widen strictures or narrowed segments of the esophagus by progressively enlarging the lumen, employed in the management of dysphagia or post-procedural esophageal stenosis within the ENT specialty. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket notification. Product code KCF is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KCF
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K962688 | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE | Jul 25, 1996 | Substantially Equivalent | Boston Medical Products, Inc. |
| K923355 | PHARYNGEAL SALIVARY BYPASS TUBE | Oct 06, 1992 | Substantially Equivalent | Boston Medical Products, Inc. |
| K812305 | MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE | Sep 08, 1981 | Substantially Equivalent | Boston Medical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.