Sunmed Foley Catheters
FDA 510(k) K062112 · Sunmed, Inc.
510(k) numberK062112
Submission
- Device name
- Sunmed Foley Catheters
- Applicant
- Sunmed, Inc.
Appollo Beach, FL, US - Received
- July 24, 2006
- Decision date
- June 4, 2007
- 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 |
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| 510(k) | Device | Decision |
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| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | 08/02/2024SE |
| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | 03/28/2013SE |
| K081805 | CuffalertBSK · Traditional | 11/14/2008SE |
| K955632 | Orthoplug Soft Bone DesignLZN · Traditional | 02/27/1996SE |
| K955631 | Orthoplug Hard Bone DesignLZN · Traditional | 02/27/1996SE |
| K921263 | Sunlite LaryngoscopeCCW · Traditional | 06/01/1993SE |
Questions and answers
When was Sunmed Foley Catheters cleared by the FDA?
Sunmed Foley Catheters (K062112) received a 510(k) decision of Substantially Equivalent on June 4, 2007, 315 days after the submission was received.
What is the product code of K062112?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.