Conphar Latex Foley Cath-Sterile
by Conphar, Inc. 510(k)
Active
510(k) K792109
Overview
The Conphar Latex Foley Cath-Sterile is a urological catheter designed for bladder drainage. It is classified as a Catheter, Urological, and functions by inserting into the bladder to collect urine, ensuring continuous drainage while minimizing tissue trauma through a smooth, beveled design. The device is intended for single-use medical applications in clinical settings.
This sterile, latex catheter is supplied in a single-use configuration and is intended for use in urological procedures. It is regulated under FDA 510(k) clearance (K792109) and falls under the classification of Class II medical devices. The device is packaged for individual use and must be stored under appropriate sterile conditions to maintain integrity before use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792109 | Date16 Nov 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Conphar, Inc.
Questions
What is the primary purpose of the Conphar Latex Foley Cath-Sterile, and how does its design support its function?
The Conphar Latex Foley Cath-Sterile is designed specifically for bladder drainage in urological procedures. Its smooth, beveled tip minimizes tissue trauma during insertion, ensuring patient comfort while effectively collecting urine through continuous drainage.
Is this device intended for single-use or reusable applications, and why?
This device is explicitly intended for single-use medical applications. The manufacturer emphasizes its sterile packaging and configuration, which ensures safety and hygiene for one-time clinical use only, preventing cross-contamination risks.
How should the Conphar Latex Foley Cath-Sterile be stored to maintain its sterility before use?
The device must be stored under appropriate sterile conditions to preserve its integrity. Since it is packaged for individual use, it should remain unopened and protected from contamination until ready for clinical application.
What regulatory pathway was followed for this device’s approval, and what does that mean for its use?
The Conphar Latex Foley Cath-Sterile was cleared through the FDA 510(k) process (K792109) under the classification of a Class II medical device, meaning it underwent a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device. This clearance confirms its compliance with FDA standards for safety and effectiveness in its intended single-use urological application.