Wellead® Latex Foley Catheter
FDA 510(k) K233094 · Well Lead Medical (Hainan) Co., Ltd.
510(k) numberK233094
Submission
- Device name
- Wellead® Latex Foley Catheter
- Applicant
- Well Lead Medical (Hainan) Co., Ltd.
Haikou, CN - Received
- September 26, 2023
- Decision date
- June 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJC – Catheter, Urological (Antimicrobial) And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code MJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040658 | Bardex I.C. Latex Foley CatheterMJC · Traditional | C.R. Bard, Inc. | 09/29/2004SE |
| K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitMJC · Traditional | Rochester Medical Corp. | 06/10/2004SE |
| K000251 | Spectrum Silicone Foley CatheterMJC · Traditional | Cook Urological, Inc. | 08/30/2000SE |
| K001143 | Release NF Antibacterial Foley Catheter, Antibacterial Personal CatheterMJC · Traditional | Rochester Medical Corp. | 07/07/2000SE |
| K993464 | Bardex I.C. Pediatric Foley CatheterMJC · Abbreviated | C.R. Bard, Inc. | 12/10/1999SE |
| K984136 | Bardex Lubri-Sil I.C. Foley CatheterMJC · Traditional | Bard Medical Div. | 02/16/1999SE |
| K983101 | Bardex I.C 4-WAY Foley Catheter Model 1865SIXX XX = 18,20,22,24MJC · Abbreviated | C.R. Bard, Inc. | 11/03/1998SE |
| K971627 | Silicone Antibacterial Foley CatheterMJC · Traditional | Rochester Medical Corp. | 01/13/1998SE |
| K910318 | Bard(R) Hydrogel/Silver-Coated Foley CatheterMJC · Traditional | C.R. Bard, Inc. | 08/18/1994SE |
Questions and answers
When was Wellead® Latex Foley Catheter cleared by the FDA?
Wellead® Latex Foley Catheter (K233094) received a 510(k) decision of Substantially Equivalent on June 6, 2024, 254 days after the submission was received.
What is the product code of K233094?
The FDA product code is MJC – Catheter, Urological (Antimicrobial) And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.5130.