Conphar Laryngoscope
by Conphar, Inc. 510(k)
Active
510(k) K813297
Overview
The Conphar Laryngoscope is a medical device classified as a Laryngoscope and Nasopharyngoscope, designed for visual examination of the larynx, nasopharynx, and surrounding structures. It facilitates direct visualization of the airway and upper respiratory tract, aiding in diagnostic and procedural interventions within the ear, nose, and throat (ENT) specialty. The device is intended for use by healthcare professionals in clinical settings to assess anatomical conditions, guide interventions, or assist in airway management.
This laryngoscope is supplied as a reusable medical instrument, adhering to regulatory standards for ENT procedures. It is intended for use in sterile or semi-sterile environments, depending on clinical protocol, and must be properly cleaned, disinfected, or sterilized between uses to maintain safety and functionality. The device is classified under FDA Product Code EQN and holds a Traditional 510(k) clearance (K813297) with a decision date of January 22, 1982. Compliance with 21 CFR Part 874.4760 ensures its regulatory standing for intended medical applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813297 | Date22 Jan 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EQN
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.4760
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Other devices from Conphar, Inc.
Questions
What is the Conphar Laryngoscope used for in clinical practice?
The Conphar Laryngoscope is designed for visual examination of the larynx, nasopharynx, and surrounding structures within the ear, nose, and throat (ENT) specialty. It aids healthcare professionals in assessing anatomical conditions, guiding interventions, and assisting with airway management during diagnostic or procedural interventions.
Is the Conphar Laryngoscope intended for single-use or reusable applications?
The Conphar Laryngoscope is supplied as a reusable medical instrument. To ensure safety and functionality, it must be properly cleaned, disinfected, or sterilized between uses, adhering to regulatory standards for ENT procedures in sterile or semi-sterile environments.
What regulatory approval does the Conphar Laryngoscope hold?
The Conphar Laryngoscope holds a Traditional 510(k) clearance (K813297) from the FDA, classified under Product Code EQN. It was determined substantially equivalent to a predicate device and reviewed by the Ear, Nose, and Throat (EN) Advisory Committee, ensuring compliance with 21 CFR Part 874.4760.
What types of clinical environments is this laryngoscope suitable for?
The device is intended for use in clinical settings by healthcare professionals, where sterile or semi-sterile protocols are followed. Its design supports diagnostic and procedural interventions in ENT specialties, requiring adherence to cleaning and sterilization procedures between uses.
How does the Conphar Laryngoscope differ from other reusable laryngoscopes?
The Conphar Laryngoscope is specifically designed for direct visualization of the airway and upper respiratory tract, with a focus on ENT applications. Unlike other reusable laryngoscopes, it is cleared under FDA Product Code EQN and includes multiple registration numbers (e.g., 3003761012, 3005747797), reflecting its regulatory compliance and intended use for both diagnostic and procedural purposes in ENT.