Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable Endosheath Systems

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K072088 ↗

FDA Product Code

EOX

Device Class

Class II

Regulation

21 CFR Part 874.4710

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Flexible Nasopharyngo-Laryngoscope and Endosheath

  Class II

  FDA 510(k) K942265 Active Cleared 22 Dec 1995

• Modification to Vision Sciences Endosheath System

  Class II

  FDA 510(k) K024095 Active Cleared 9 Jan 2003

• Vision-Sciences Cst-2000 Flexible Cystoscope with Slide-on Endosheath System

  Class II

  FDA 510(k) K040215 Active Cleared 15 Apr 2004

• Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, DPU-5000/DPU-5050 Video Processor

  Class II

  FDA 510(k) K102733 Active Cleared 18 May 2011

• Vision-Sciences Cst-5000 Video Cystoscope with Endosheath System

  Class II

  FDA 510(k) K072180 Active Cleared 18 Dec 2007

• Flexible Hysteroscope with Endosheath System

  Class II

  FDA 510(k) K071127 Active Cleared 16 Nov 2007

See all devices from Vision-Sciences, Inc. →

• What is the primary use case for the Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable Endosheath Systems?

  This device is designed specifically for trans-nasal examination of the esophagus, allowing clinicians to visualize the upper gastrointestinal tract in real-time. The integrated digital video processor enhances image clarity, making it ideal for Ear, Nose, and Throat (ENT) procedures where detailed visualization of the esophageal lining is required.

• How is the Flexible Trans-Nasal Video Esophagoscope supplied, and what does this mean for clinical workflow?

  The system is supplied as a reusable esophagoscope paired with sterile, single-use disposable Endosheath systems. This design reduces cross-contamination risk between patients while minimizing maintenance requirements for the reusable scope, streamlining workflow and ensuring hygiene.

• Are there different sizes or models available for this device, and if so, how might they be selected?

  The provided data lists multiple registration numbers and FEI numbers, indicating the availability of multiple models or variants (e.g., 3005465238, 3003782610, etc.). While specific sizes or model distinctions (e.g., pediatric vs. adult) aren’t detailed here, these identifiers typically correspond to variations in length, diameter, or insertion depth. Selection would depend on patient anatomy and clinical preference, with the manufacturer likely offering guidance based on these factors.

• How should the disposable Endosheath systems be stored, and what sterility assurance does Vision-Sciences provide?

  The disposable Endosheath systems are described as sterile and single-use, which implies they are pre-packaged and terminally sterilized by the manufacturer. Storage should follow the manufacturer’s instructions (e.g., sealed packaging, protected from moisture/dust, and within expiration dates). Since they are sterile upon opening, no additional sterilization is required before use.

• What regulatory pathway was followed for this device, and what does this mean for clinicians or purchasers?

  The device holds a Special 510(k) clearance under FDA regulation 21 CFR 874.4710, with a decision date of August 29, 2007. This means the manufacturer demonstrated to the FDA that their device is substantially equivalent to a legally marketed predicate device (not currently specified here). Clinicians or purchasers can rely on this clearance as evidence of regulatory review for safety and performance, though they should always verify the latest compliance status with Vision-Sciences or the FDA’s database.