Silicone Antibacterial Foley Catheter
FDA 510(k) K971627 · Rochester Medical Corp.
510(k) numberK971627
Submission
- Device name
- Silicone Antibacterial Foley Catheter
- Applicant
- Rochester Medical Corp.
Stewartville, MN, US - Received
- May 2, 1997
- Decision date
- January 13, 1998
- 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 |
|---|---|---|---|
| K233094 | Wellead® Latex Foley CatheterMJC · Traditional | Well Lead Medical (Hainan) Co., Ltd. | 06/06/2024SE |
| 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 |
| K910318 | Bard(R) Hydrogel/Silver-Coated Foley CatheterMJC · Traditional | C.R. Bard, Inc. | 08/18/1994SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K122785 | Hydrosil; Magic; Personal CatheterEZD · Traditional | 05/14/2013SE |
| K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitMJC · Traditional | 06/10/2004SE |
| K001143 | Release NF Antibacterial Foley Catheter, Antibacterial Personal CatheterMJC · Traditional | 07/07/2000SE |
| K000723 | Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and…KOD · Traditional | 05/19/2000SE |
| K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…EZL · Traditional | 07/08/1998SE |
| K970704 | Personal CatheterGBM · Traditional | 03/13/1997SE |
| K952082 | Rochester Medical Corporation Silicone Male External CatheterEXJ · Traditional | 07/18/1995SE |
| K941692 | Female Length All Silicone Urological CatheterEZL · Traditional | 03/06/1995SE |
| K943851 | All Silicone Intermittent CatheterGBM · Traditional | 01/31/1995SE |
| K923136 | Male External CatheterEXJ · Traditional | 12/03/1992SE |
Questions and answers
When was Silicone Antibacterial Foley Catheter cleared by the FDA?
Silicone Antibacterial Foley Catheter (K971627) received a 510(k) decision of Substantially Equivalent on January 13, 1998, 256 days after the submission was received.
What is the product code of K971627?
The FDA product code is MJC – Catheter, Urological (Antimicrobial) And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.5130.