Percufix Catheter Cuff
by Medi-Tech, Inc. 510(k)
Active
510(k) K842890
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842890 | Date4 Sep 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 24 Sep 2026
The Percufix Catheter Cuff is a urological device designed to function as a component for catheter systems. It is used to provide secure fixation for the catheter during clinical use.
This device is supplied by Medi-Tech, Inc. and is regulated as a Class 2 medical device under FDA 510(k) clearance K842890. It is available in kit configurations that may include the cuff, a catheter, and cable ties.
Other devices from Medi-Tech, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the primary purpose of the Percufix Catheter Cuff?
The Percufix Catheter Cuff is designed to function as a component within urological catheter systems. Its primary clinical function is to provide secure fixation for the catheter while it is in use.
How is the Percufix Catheter Cuff supplied?
This device is supplied by Medi-Tech, Inc. in various kit configurations. These kits may include the cuff itself, a catheter, and cable ties to facilitate the fixation process.
What is the regulatory status of this device?
The Percufix Catheter Cuff is regulated as a Class 2 medical device. It has received FDA 510(k) clearance under the number K842890.