Catheters, Male, Female
by Zinnanti Surgical Instruments, Inc. 510(k)
Active
510(k) K892691
Overview
These catheters are designed for urological and gastrointestinal applications, serving as tubular devices inserted into the body to drain fluids, administer medications, or facilitate diagnostic procedures. They are classified as urological catheters and may be used in both male and female patients for urinary drainage, cystoscopy, or other endoscopic interventions. The devices are intended for single-use and are engineered to ensure compatibility with standard medical instrumentation.
The catheters are supplied sterile and intended for use in clinical settings such as hospitals, outpatient clinics, and surgical centers. They are classified under FDA product code KOD and fall under Class II regulatory status, with a clearance decision dated June 23, 1989. Sizes and specifications are referenced in the associated FDA submission (K892691) and are intended for single-patient use only. No MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892691 | Date23 Jun 1989 | 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- Withdrawn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 Zinnanti Surgical Instruments, Inc.
Questions
What are these catheters primarily used for?
These catheters are designed for urological and gastrointestinal applications, serving as tubular devices inserted into the body to drain fluids, administer medications, or assist in diagnostic procedures. They are commonly used for urinary drainage in both male and female patients, as well as for cystoscopy or other endoscopic interventions.
Are these catheters intended for single-use or reuse?
These catheters are explicitly intended for single-use only. They are engineered to ensure patient safety and sterility, preventing cross-contamination between patients. Reuse is not recommended or supported by the manufacturer.
How are these catheters supplied, and where can they be used?
The catheters are supplied sterile and are intended for use in clinical settings such as hospitals, outpatient clinics, and surgical centers. Sterility ensures they are ready for immediate use without additional preparation, making them suitable for sterile environments where urological or gastrointestinal procedures are performed.
What regulatory status do these catheters hold?
These catheters hold FDA clearance under the 510(k) pathway, classified under product code KOD and categorized as Class II medical devices. The clearance decision was made on June 23, 1989, and they are intended for use in accordance with FDA guidelines for urological catheters.
Are there specific sizes or models available, and how can I find detailed specifications?
The catheters come in multiple sizes and models, as referenced in the FDA submission (K892691). Detailed specifications, including dimensions and technical details, can be found in the associated FDA submission documentation. The manufacturer provides these specifications to ensure compatibility with clinical needs and standard medical instrumentation.