Hydrogel-Coated Urethral Catheters and Drains
FDA 510(k) K910197 · C.R. Bard, Inc.
510(k) numberK910197
Submission
- Device name
- Hydrogel-Coated Urethral Catheters and Drains
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- January 16, 1991
- Decision date
- August 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EZC – Catheter, Coude
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222279 | Rusch Intermittent Urethral CathetersEZC · Special | Teleflex Medical | 08/29/2022SE |
| K173596 | Rusch Intermittent Urethral CathetersEZC · Traditional | Teleflex Medical | 01/29/2018SE |
| K946282 | Universal Urethral CatheterEZC · Traditional | Louisville Laboratories, Inc. | 03/31/1995SE |
| K913341 | Bard(R) Coude Tip Temperature Sensing CatheterEZC · Traditional | C.R. Bard, Inc. | 01/27/1992SE |
| K910846 | Bard Latex Urinary Catheters Drains- Designs ModifEZC · Traditional | C.R. Bard, Inc. | 08/16/1991SEKD |
| K910195 | Bard Hydrogel-Coated Foley CathetersEZC · Traditional | C.R. Bard, Inc. | 08/09/1991SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Hydrogel-Coated Urethral Catheters and Drains cleared by the FDA?
Hydrogel-Coated Urethral Catheters and Drains (K910197) received a 510(k) decision of Substantially Equivalent on August 9, 1991, 205 days after the submission was received.
What is the product code of K910197?
The FDA product code is EZC – Catheter, Coude, a Class II (moderate risk) device regulated under 21 CFR 876.5130.