Jesberg Esophagoscope
by Zinnanti Surgical Instruments, Inc. 510(k)
Active
510(k) K892259
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892259 | Date16 Jun 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EOX
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.4710
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Jesberg Esophagoscope is an esophagoscope, which is a medical device used to visually examine the esophagus. It is classified as a flexible or rigid esophagoscope. The device is used in the field of ear, nose, and throat medical specialty.
The Jesberg Esophagoscope is supplied by Zinnanti Surgical Instruments, Inc. and has been cleared by the FDA with a 510K clearance, specifically K892259. The device has a product code of EOX and is classified as a Class II device with special controls. It is available in a size of 504 mm.
Other devices from Zinnanti Surgical Instruments, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Jesberg Esophagoscope used for?
The Jesberg Esophagoscope is a medical device used to visually examine the esophagus. It is classified as either a flexible or rigid esophagoscope and is utilized in the ear, nose, and throat medical specialty.
How is the Jesberg Esophagoscope supplied?
The Jesberg Esophagoscope is supplied by Zinnanti Surgical Instruments, Inc. It is available in a size of 504mm and is classified as a Class II device with special controls.
What is the regulatory status of the Jesberg Esophagoscope?
The Jesberg Esophagoscope has been cleared by the FDA with a 510K clearance, specifically K892259. It has a product code of EOX and is classified as a Class II device with special controls.
Is the Jesberg Esophagoscope reusable or single-use?
The device data does not specify whether the Jesberg Esophagoscope is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer or product documentation.