Folysil Silicone Catheter
FDA 510(k) K233411 · Coloplast Corp.
510(k) numberK233411
Submission
- Device name
- Folysil Silicone Catheter
- Applicant
- Coloplast Corp.
Plymouth, MN, US - Received
- October 6, 2023
- Decision date
- April 15, 2024
- 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 |
| 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 |
| K231101 | Flume CatheterEZL · Special | Flume Catheter Company, Ltd. | 06/29/2023SE |
More from Flume Catheter Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | 10/06/2025SE |
| K251116 | Luja CoudéEZD · Traditional | 06/27/2025SE |
| K250270 | Luja SetEZD · Special | 04/17/2025SE |
| K242049 | SureCath SetEZD · Traditional | 11/26/2024SE |
| K241210 | Luja CoudeEZD · Traditional | 11/21/2024SE |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…FED · Traditional | 11/12/2024SE |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…FRO · Traditional | 03/22/2024SE |
| K233101 | Luja Coude (20108 Male CH18 - large packaging)EZD · Special | 10/26/2023SE |
Questions and answers
When was Folysil Silicone Catheter cleared by the FDA?
Folysil Silicone Catheter (K233411) received a 510(k) decision of Substantially Equivalent on April 15, 2024, 192 days after the submission was received.
What is the product code of K233411?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.