Sinuscope
510(k) K940317
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940317 | Date24 May 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EOB
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.4760
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sinuscope is a Nasopharyngoscope (Flexible or Rigid), a diagnostic device used to visually examine the nasal passages, nasopharynx, and adjacent structures. It provides direct visualization of the upper airway, sinus ostia, and surrounding anatomy, aiding in the assessment of conditions such as sinusitis, nasal polyps, or structural abnormalities. Its design allows for flexible or rigid insertion, accommodating varying patient anatomies and clinical needs.
The Sinuscope is supplied as a reusable medical device, intended for use in clinical settings such as otolaryngology offices, hospitals, or outpatient care facilities. It is classified under FDA product code EOB and falls under Class II regulatory classification, with an FDA 510(k) clearance (K940317) granted in 1995 via the Traditional pathway. No specific sterility or MRI safety information is provided in the regulatory data, though standard surgical aseptic techniques would apply in clinical use. The device is distributed by Stephen Chakoff, Inc., based in Miami, FL.
Other devices from Stephen Chakoff, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Sinuscope used for in clinical practice?
The Sinuscope is a nasopharyngoscope designed to provide direct visualization of the nasal passages, nasopharynx, and adjacent structures. Clinicians use it to assess conditions such as sinusitis, nasal polyps, or structural abnormalities in the upper airway. Its flexible or rigid design accommodates varying patient anatomies, making it versatile for otolaryngology exams in offices, hospitals, or outpatient care.
Is the Sinuscope supplied as a single-use or reusable device?
The Sinuscope is supplied as a reusable medical device. It is intended for repeated use in clinical settings, provided standard surgical aseptic techniques are followed during cleaning and reprocessing. Reusability extends its utility in environments where cost efficiency and device availability are priorities.
What regulatory pathway was used for the Sinuscope’s FDA clearance?
The Sinuscope received FDA clearance under the Traditional 510(k) pathway, granted on May 24, 1995, with clearance number K940317. The device was classified as substantially equivalent to a predicate and falls under FDA product code EOB, categorized as a Class II medical device. This pathway ensures it meets regulatory standards for safety and effectiveness.
Are there specific models or sizes available for the Sinuscope?
The Sinuscope is available in multiple models, as indicated by the diverse FEI numbers listed in the regulatory data. These variations likely correspond to different lengths, diameters, or tip configurations to suit specific clinical needs. While exact specifications (e.g., measurements) aren’t detailed in the provided data, the flexibility in design supports adaptability for pediatric to adult patients.
How should the Sinuscope be stored to maintain its integrity?
Though specific storage instructions aren’t provided in the regulatory data, reusable medical devices like the Sinuscope typically require clean, dry storage in a protected environment to prevent contamination or damage. Manufacturers often recommend storing in a sealed case or pouch, away from direct sunlight or extreme temperatures, and following the manufacturer’s reprocessing guidelines to ensure longevity and sterility before reuse.