Device Information
Device Specifications:
This 2-Way 100% Silicone ClearTract Catheter is a two-way Foley catheter designed for single use. Made from medical-grade silicone, it includes two lumens—one for balloon inflation/deflation and the other for drainage. It supports urinary drainage through the urethra, suprapubic, or nephrostomy placement. The new 24Fr catheter size was introduced with this model.
Indications
This device facilitates urinary drainage through insertion into the bladder via the urethra or other routes. It is intended for use in both adult and pediatric patients.
Intended Use
The catheter is used to drain urine from the bladder. It is suitable for adults and children under medical supervision.
Availability
This device is prescription-only.
Study Results
Nonclinical and Safety Testing: Tests confirmed compliance with ISO 10993-1:2018 for biocompatibility. Sterilization met ANSI/AAMI/ISO 11135:2014 standards. Key performance tests included flow rate, balloon resistance, traction response, and deflation reliability. All tests met predefined acceptance criteria.
Regulatory Information
- Regulation Number: 21 CFR 876.5130
- Regulatory Class: II
- Product Code: EZL
- 510(k) Number: K233013
This device must adhere to regulations covering general medical device controls, biocompatibility standards, and proper manufacturing practices outlined in 21 CFR Parts 800-898.
Manufacturer Information
- Name: SILQ Technologies Corporation
- Address: 323 Sunny Isles Blvd., 7th Floor, Sunny Isles Beach, FL 33160
- Contact Person: Aaron Rogers
Predicate Device Information
- Primary Predicate Device: 2-Way 100% Silicone ClearTract Catheter (K222118)
- Reference Device: Silicone Foley Catheter for Single Use (K172807)
This catheter builds on the predicate with the introduction of a new 24Fr size. Both predicate and current devices share the same intended use, though the subject device features slight design modifications without compromising safety or effectiveness.
Implications
The catheter ensures efficient urinary drainage with flexibility for different insertion methods. Its modifications provide expanded size options to address diverse patient needs.
References
- 2-Way 100% Silicone ClearTract Catheter. 510(k) Number: K233013. SILQ Technologies Corporation. FDA Summary. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233013
- https://www.silq.tech/
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