Identifiers
- 510(k) Number
- K173340 FDA 510(k)
- FDA Product Code
- EZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Yikang Latex Foley Catheter is a retention-type balloon catheter designed for urinary drainage. It is classified as a Class II medical device and intended for placement through the urethra into the bladder to facilitate the drainage of urine and other fluids.
This device is supplied as a single-use, sterile product and is manufactured in multiple sizes as indicated by the registration numbers. It is intended for use in urological procedures and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of July 13, 2018. The catheter is intended for MRI-unspecified use and is distributed by Jiangxi Yikang Medical Instrument Group Co., Ltd.
Frequently asked questions
What is the Yikang Latex Foley Catheter used for?
The Yikang Latex Foley Catheter is a retention-type balloon catheter designed for urinary drainage. It is intended for placement through the urethra into the bladder to facilitate the drainage of urine and other fluids during urological procedures.
Is the Yikang Latex Foley Catheter sterile and for single use only?
Yes, the device is supplied as a single-use, sterile product, meaning it is intended for one-time use only and must not be reprocessed or reused to ensure patient safety and maintain sterility.
How is the Yikang Latex Foley Catheter supplied and what sizes are available?
The catheter is manufactured in multiple sizes as indicated by the registration numbers listed in the device data, though specific French sizes are not detailed in the provided information. It is distributed by Jiangxi Yikang Medical Instrument Group Co., Ltd. and supplied in sterile packaging for single use.
What regulatory pathway was used for the Yikang Latex Foley Catheter’s clearance?
The device received FDA 510(k) clearance under the Traditional pathway, with a decision date of July 13, 2018, and was found substantially equivalent to a predicate device under regulation number 876.5130.
Is the Yikang Latex Foley Catheter safe for use in MRI environments?
The device is intended for MRI-unspecified use, meaning its safety and compatibility in magnetic resonance imaging environments have not been established, and it should not be used in MRI settings unless specifically evaluated and labeled as MRI-safe or MRI-conditional.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Jiangxi Yikang Medical Instrument Group Co., Ltd.,_Foley catheters ..., Foley Catheters Manufacturer | ChinaYikang, Yikang Latex Foley Catheter (K173340) — FDA 510(k) | Innolitics, Jiangxi Yikang Medical Instrument Group Co., Ltd., Yikang Latex Foley Catheter - healthcareequipment.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173340 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangxi Yikang Medical Instrument Group Co., Ltd.
Sources (1)
- FDA 510(k) K173340 24 fields · synced Sep 19, 2026