Haematuria Catheters
by Warne Surgical Products, Ltd.
510(k) K841511
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841511 | Date12 Jul 1984 | 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- Withdrawn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
- KOD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Haematuria Catheters are urological catheters, classified as a device class 2 medical device. They are substantially equivalent and used in the field of urology. The device is designed to be used in medical settings for urological procedures.
The Haematuria Catheters are supplied by Warne Surgical Products, Ltd. and have been granted FDA 510(k) clearance, with the clearance number K841511. The device is regulated under the product code KOD and regulation number 876.5130. The catheters are available with various registration numbers and fei numbers as listed in the device specifications.
Other devices from Warne Surgical Products, Ltd.
Questions
AI-generated answers, 27 Sep 2026
What are Haematuria Catheters used for?
Haematuria Catheters are used in the field of urology for urological procedures in medical settings.
Are Haematuria Catheters sterile?
The device data does not specify the sterility of Haematuria Catheters, it is recommended to consult the manufacturer or device specifications for this information.
What is the regulatory status of Haematuria Catheters?
Haematuria Catheters have been granted FDA 510(k) clearance with the clearance number K841511, and are regulated under the product code KOD and regulation number 876.5130.