Spectrum Silicone Foley Catheter
FDA 510(k) K000251 · Cook Urological, Inc.
510(k) numberK000251
Submission
- Device name
- Spectrum Silicone Foley Catheter
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- January 27, 2000
- Decision date
- August 30, 2000
- 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 |
| 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 |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | 05/06/2011SE |
| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | 10/09/2009SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
| K082536 | Cook Wire GuidesOCY · Traditional | 10/27/2008SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
Questions and answers
When was Spectrum Silicone Foley Catheter cleared by the FDA?
Spectrum Silicone Foley Catheter (K000251) received a 510(k) decision of Substantially Equivalent on August 30, 2000, 216 days after the submission was received.
What is the product code of K000251?
The FDA product code is MJC – Catheter, Urological (Antimicrobial) And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.5130.