Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, DPU-5000/DPU-5050 Video Processor
510(k) K102733
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102733 | Date18 May 2011 | 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- Withdrawn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
- Full name
- Vision-Sciences Ent-5000 Video ENT Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor
- 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, 19 Sep 2026
The ENT-5000 Video ENT Scope with Endosheath Technology is a nasopharyngoscope (flexible or rigid) designed for flexible endoscopic visualization of the upper airway, vocal cords, and nasal passages. It integrates CCD-based imaging for high-resolution video output and incorporates Endosheath Technology to create a protective barrier during insertion, reducing patient discomfort through its small-diameter insertion tube.
This device is supplied as a reusable scope paired with the DPU-5000/DPU-5050 video processor for real-time imaging. It is classified as Class II under FDA regulation 874.4760 and has received FDA 510K clearance via a Substantially Equivalent determination by the Ear, Nose, and Throat (EN) Advisory Committee. The scope is intended for use in diagnostic endoscopic procedures within the upper airway and nasal cavities, with no specific sterility or MRI safety restrictions noted in the data.