Amself Closed Catheterization System
FDA 510(k) K082831 · Amsino International, Inc.
510(k) numberK082831
Submission
- Device name
- Amself Closed Catheterization System
- Applicant
- Amsino International, Inc.
Pomona, CA, US - Received
- September 26, 2008
- Decision date
- October 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K011055 | The O'Neil Sterile Field Urinary Catheter Kit with Prep PadsFCM · Traditional | Go Medical Industries Pty. , Ltd. | 06/06/2001SE |
| K010420 | Rusch Mmg/O'Neil CatheterFCM · Traditional | Rusch, Inc. | 05/09/2001SE |
| K003873 | Mentor Self-Cath Closed SystemFCM · Traditional | Mentor Corp. | 03/29/2001SE |
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| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 07/12/2019SE |
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Questions and answers
When was Amself Closed Catheterization System cleared by the FDA?
Amself Closed Catheterization System (K082831) received a 510(k) decision of Substantially Equivalent on October 23, 2008, 27 days after the submission was received.
What is the product code of K082831?
The FDA product code is FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), a Class II (moderate risk) device regulated under 21 CFR 876.5130.