Busse Hospital Disposables Urethral Catheter
510(k) K041464
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041464 | Date5 Nov 2004 | 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- Withdrawn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
- EZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Busse Hospital Disposables Urethral Catheter is a straight, radiopaque urological device designed for urethral use. It functions as a catheter to facilitate drainage or access within the urinary tract.
This device is authorized under FDA 510(k) clearance. It is categorized under the gastroenterology and urology medical specialties.
Other devices from Busse Hospital Disposables
Questions
AI-generated answers, 6 Oct 2026
What is the primary purpose of this urethral catheter?
The Busse Hospital Disposables Urethral Catheter is a straight, radiopaque device designed for use within the urinary tract to facilitate drainage or access.
What is the regulatory status of this device?
This device is authorized under FDA 510(k) clearance, which indicates it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Which medical specialties is this catheter intended for?
The device is categorized under the gastroenterology and urology medical specialties and is identified by the product code EZD.