Ultrasound Video Bronchoscope, Model EB-1970UK
510(k) K081518
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081518 | Date5 Sep 2008 | 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- Withdrawn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
- EOQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.4680
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
An ultrasound video bronchoscope is a device that combines endoscopic visualization with ultrasound imaging to examine the bronchial tree and surrounding structures. This device, model EB-1970UK, is designed for use in bronchoscopic procedures to provide real-time imaging of lymph nodes and tissues adjacent to the airways.
It is supplied as a reusable endoscopic system intended for use in clinical settings such as hospitals or outpatient centers. The device requires appropriate cleaning and disinfection between uses in accordance with manufacturer guidelines. Regulatory authorization is based on FDA 510(k) clearance under product code EOQ, with a determination of substantial equivalence to a legally marketed predicate device.
Other devices from Pentax Medical Company
Questions
AI-generated answers, 27 Sep 2026
What is the EB-1970UK ultrasound video bronchoscope used for?
The EB-1970UK is designed for bronchoscopic procedures to provide real-time ultrasound imaging of lymph nodes and tissues adjacent to the airways, combining endoscopic visualization with ultrasound to examine the bronchial tree and surrounding structures.
Is the EB-1970UK ultrasound video bronchoscope reusable or single-use?
The EB-1970UK is supplied as a reusable endoscopic system, meaning it can be used multiple times provided it undergoes appropriate cleaning and disinfection between uses in accordance with the manufacturer's guidelines to ensure patient safety and device integrity.
What regulatory pathway was used for the EB-1970UK ultrasound video bronchoscope?
The EB-1970UK received regulatory authorization through the FDA 510(k) clearance process, specifically under product code EOQ, with a determination of substantial equivalence to a legally marketed predicate device, as indicated by the decision code SESE and clearance type Traditional.