Rusch Intermittent Urethral Catheters
FDA 510(k) K173596 · Teleflex Medical
510(k) numberK173596
Submission
- Device name
- Rusch Intermittent Urethral Catheters
- Applicant
- Teleflex Medical
Morrisville, NC, US - Received
- November 21, 2017
- Decision date
- January 29, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K910197 | Hydrogel-Coated Urethral Catheters and DrainsEZC · Traditional | C.R. Bard, Inc. | 08/09/1991SE |
| K910195 | Bard Hydrogel-Coated Foley CathetersEZC · Traditional | C.R. Bard, Inc. | 08/09/1991SE |
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Questions and answers
When was Rusch Intermittent Urethral Catheters cleared by the FDA?
Rusch Intermittent Urethral Catheters (K173596) received a 510(k) decision of Substantially Equivalent on January 29, 2018, 69 days after the submission was received.
What is the product code of K173596?
The FDA product code is EZC – Catheter, Coude, a Class II (moderate risk) device regulated under 21 CFR 876.5130.