Rusch Silicone Foley Catheter
FDA 510(k) K980870 · Rusch, Inc.
510(k) numberK980870
Submission
- Device name
- Rusch Silicone Foley Catheter
- Applicant
- Rusch, Inc.
Jeffrey, NH, US - Received
- March 4, 1998
- Decision date
- June 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZL – Catheter, Retention Type, Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional | Sentinel Medical Technologies, | 09/04/2026SE |
| K262056 | Rusch Latex Gold Foley CatheterEZL · Traditional | Teleflex Medical Sdn. Bhd. | 08/05/2026SE |
| K252537 | Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflex Medical Sdn. Bhd. | 01/20/2026SE |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional | Guangdong Ecan Medical Co., Ltd. | 06/16/2025SE |
| K241424 | InnoCare Specialty Foley CatheterEZL · Traditional | Innocare Urologics, LLC | 09/18/2024SE |
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | Teleflexmedical, Inc. | 08/01/2024SE |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional | Sentinel Medical Technologies, LLC | 04/17/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | Coloplast Corp. | 04/15/2024SE |
| K233013 | 2-Way 100% Silicone Cleartract CatheterEZL · Traditional | Silq Technologies Corporation | 01/23/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflexmedical, Inc. | 07/27/2023SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010420 | Rusch Mmg/O'Neil CatheterFCM · Traditional | 05/09/2001SE |
| K993528 | Rusch Emergency MaskCBP · Traditional | 05/31/2000SE |
| K993194 | Rusch Manual Resuscitator BagBTM · Traditional | 03/24/2000SE |
| K974419 | Rusch Simplastic Councill Tip CatheterEZL · Traditional | 01/27/1998SE |
| K963779 | Rusch Enteral Feeding TubeFPD · Traditional | 05/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | 02/07/1997SE |
| K963993 | Rusch Simplastic Foley Catheterization SetFCM · Traditional | 12/17/1996SE |
| K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileJOH · Traditional | 06/28/1996SE |
| K955495 | Rusch Reinforced Trachael Tube Cuffed, SterileBTR · Traditional | 06/27/1996SE |
| K953963 | Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial…BTS · Traditional | 11/27/1995SE |
Questions and answers
When was Rusch Silicone Foley Catheter cleared by the FDA?
Rusch Silicone Foley Catheter (K980870) received a 510(k) decision of Substantially Equivalent on June 9, 1998, 97 days after the submission was received.
What is the product code of K980870?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.