Amsure 3-WAY Hydrophilic Latex Foley Catheter
FDA 510(k) K101824 · Amsino International, Inc.
510(k) numberK101824
Submission
- Device name
- Amsure 3-WAY Hydrophilic Latex Foley Catheter
- Applicant
- Amsino International, Inc.
Pomona, CA, US - Received
- July 1, 2010
- Decision date
- September 13, 2010
- 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 |
|---|---|---|
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | 05/04/2026SE |
| K220230 | AMSure Enteral Feeding PumpLZH · Traditional | 11/10/2022SE |
| K220267 | AMSafe NeuFlo Needleless ConnectorFPA · Traditional | 10/07/2022SE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 03/22/2022SE |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding SetLZH · Traditional | 09/25/2020SE |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 07/12/2019SE |
| K181445 | AMSure Hydrophilic Intermittent CatheterEZD · Traditional | 10/01/2018SE |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound FlushFRO · Traditional | 09/07/2018SE |
| K173665 | AMSafe Sure-Lok Needle-Free ConnectorFPA · Traditional | 09/05/2018SE |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterEZL · Traditional | 09/04/2018SE |
Questions and answers
When was Amsure 3-WAY Hydrophilic Latex Foley Catheter cleared by the FDA?
Amsure 3-WAY Hydrophilic Latex Foley Catheter (K101824) received a 510(k) decision of Substantially Equivalent on September 13, 2010, 74 days after the submission was received.
What is the product code of K101824?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.