Aq Hydrophilic Urological Catheters
FDA 510(k) K962004 · Cook Urological, Inc.
510(k) numberK962004
Submission
- Device name
- Aq Hydrophilic Urological Catheters
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- May 22, 1996
- Decision date
- June 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EYB – Catheter, Ureteral, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
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| K183323 | UPJ Occlusion Balloon CatheterEYB · Traditional | Cook Incorporated | 08/05/2019SESK |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterEYB · Traditional | Cook Incorporated | 06/17/2019SESK |
| K182122 | Ureteric CathetersEYB · Traditional | Coloplast Corp. | 10/04/2018SE |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterEYB · Traditional | Cook Incorporated | 09/14/2018SE |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB · Traditional | Coloplast Corp. | 12/21/2017SE |
| K133750 | Occluder Occlusion Balloon CatheterEYB · Traditional | Boston Scientific Corporation | 01/08/2014SE |
| K092250 | Medline Red Rubber Urethral CatheterEYB · Traditional | Medline Industries, Inc. | 01/21/2010SE |
| K083788 | Endo Optiks Urological Catheter for Endoscopy, Model SessrEYB · Traditional | Endooptiks, Inc. | 03/03/2009SE |
More from Endooptiks, 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 Aq Hydrophilic Urological Catheters cleared by the FDA?
Aq Hydrophilic Urological Catheters (K962004) received a 510(k) decision of Substantially Equivalent on June 11, 1996, 20 days after the submission was received.
What is the product code of K962004?
The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.