Rusch FloCath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
510(k) K183461
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK183461 | Date8 May 2019 | 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- Withdrawn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
- GBM
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESK Substantially Equivalent — Kit
Overview
AI-generated summary, 1 Oct 2026
The Rusch FloCath Hydrophilic Intermittent Catheter and Rusch MMG Hydrophilic Intermittent Catheter are urethral catheters designed for intermittent bladder drainage. These devices feature a hydrophilic coating that reduces friction during insertion, facilitating easier and more comfortable catheterization for patients. They are intended for single-use applications in urological and gastroenterological procedures, helping to manage urinary retention or obstruction.
These catheters are supplied sterile and intended for single-use only. They are classified as Class II medical devices under FDA regulations (510(k) clearance) and are available in various French sizes. The hydrophilic coating requires hydration with sterile saline prior to use, as specified in the packaging instructions. The devices are intended for use in clinical settings where aseptic techniques are maintained, and their design supports reduced risk of urinary tract infections when used correctly.
Other devices from Teleflex Medical, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Rusch Flocath Hydrophilic Intermittent Catheter used for?
The Rusch Flocath Hydrophilic Intermittent Catheter is designed specifically for intermittent bladder drainage in urological and gastroenterological procedures. Its hydrophilic coating reduces friction during insertion, making catheterization more comfortable for patients experiencing urinary retention or obstruction. This feature helps minimize discomfort and supports proper bladder emptying when used correctly.
How is the hydrophilic coating activated before use?
The hydrophilic coating on the Rusch Flocath catheter requires hydration with sterile saline prior to use, as outlined in the packaging instructions. This activation process ensures the coating lubricates effectively, reducing insertion resistance and improving patient comfort during catheterization.
Are these catheters reusable or intended for single-use?
The Rusch Flocath Hydrophilic Intermittent Catheter is explicitly designed for single-use only. This design choice aligns with clinical best practices to reduce the risk of urinary tract infections and maintain aseptic techniques in healthcare settings. Reusing the catheter is not recommended.
What sizes are available for the Rusch Flocath and Rusch MMG models?
The Rusch Flocath and Rusch MMG Hydrophilic Intermittent Catheters are available in multiple French sizes to accommodate different patient anatomies. The exact sizes are listed in the product specifications, ensuring compatibility with various clinical needs for intermittent catheterization.
How should these catheters be stored to maintain sterility?
The catheters are supplied sterile and must be stored in their original packaging until use to preserve sterility. The packaging is designed to protect the device from contamination, and any unopened catheters should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s storage guidelines to ensure optimal performance and safety.