Amsure Bladder Irrigation Set
FDA 510(k) K070873 · Amsino Intl., Inc.
510(k) numberK070873
Submission
- Device name
- Amsure Bladder Irrigation Set
- Applicant
- Amsino Intl., Inc.
Pomona, CA, US - Received
- March 29, 2007
- Decision date
- December 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJH – System, Irrigation, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LJH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254111 | Irrigation/Urology SetsLJH · Traditional | B.Braun Medical, Inc. | 09/10/2026SE |
| K162992 | Karl Storz UROMAT E.A.S.I.LJH · Traditional | Karl Storz Endoscopy America, Inc. | 07/07/2017SE |
| K071832 | Modifcation to: Spyglass Irrigation SystemLJH · Special | Medical Scientific, Inc. | 09/18/2007SE |
| K063700 | Spyglass Irrigation SystemLJH · Traditional | Medical Scientific, Inc. | 02/08/2007SE |
| K062551 | Nexus Irrigation Tubing SetLJH · Traditional | Nexus Medical, LLC | 12/15/2006SE |
| K042457 | Uro ProLJH · Traditional | W.O.M. World of Medicine AG | 10/25/2004SE |
| K040094 | Piggyback Irrigating SystemLJH · Abbreviated | Kosin Technologies, LLC | 04/15/2004SE |
| K023808 | Irrigation SetsLJH · Traditional | International Medsurg Connection | 03/10/2003SE |
| K010607 | Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001LJH · Traditional | Benlan, Inc. | 11/28/2001SE |
| K010122 | Continuous Flow Y-TubingLJH · Traditional | G.U.-Tek | 06/04/2001SE |
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| K973199 | Amsino Suction CatheterBSY · Traditional | 09/10/1997SE |
| K971929 | Amsino Urinary Leg BagKNX · Traditional | 08/06/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | 03/18/1997SE |
| K950780 | Amsino Cervical ScraperHHT · Traditional | 07/25/1995SE |
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Questions and answers
When was Amsure Bladder Irrigation Set cleared by the FDA?
Amsure Bladder Irrigation Set (K070873) received a 510(k) decision of Substantially Equivalent on December 19, 2007, 265 days after the submission was received.
What is the product code of K070873?
The FDA product code is LJH – System, Irrigation, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.