Uroskop C
510(k) K811807
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811807 | Date10 Aug 1981 | 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- Withdrawn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
- KPR
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
Uroskop C is a stationary X-ray system classified as a Class 2 device in radiology. It received FDA 510(k) clearance as substantially equivalent to a predicate device through the traditional pathway.
The device was cleared under K-number K811807 on August 10, 1981, and is manufactured by Siemens Corp. It is intended for use in radiology settings and is supplied as a non-sterile, reusable system. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.
Other devices from Siemens Corp.
Questions
AI-generated answers, 24 Sep 2026
What is the Uroskop C used for?
The Uroskop C is intended for use in radiology settings as a stationary X-ray system, based on its classification and clearance under product code KPR for radiographic imaging.
Is the Uroskop C sterile or single-use?
The Uroskop C is supplied as a non-sterile, reusable system, meaning it is designed for multiple uses after appropriate cleaning and is not provided in a sterile condition.
How was the Uroskop C cleared for market?
The Uroskop C received FDA 510(k) clearance through the traditional pathway as substantially equivalent to a predicate device, with clearance granted under K-number K811807 on August 10, 1981.