NHMC Irrigation Tray
FDA 510(k) K962670 · National Healthcare Mfg. Corp.
510(k) numberK962670
Submission
- Device name
- NHMC Irrigation Tray
- Applicant
- National Healthcare Mfg. Corp.
Winnipeg, Mb, CA - Received
- July 9, 1996
- Decision date
- August 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K070873 | Amsure Bladder Irrigation SetLJH · Traditional | Amsino Intl., Inc. | 12/19/2007SE |
| 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 |
More from Benlan, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972013 | National Medical Healthcare Custom OB/GYN Kits, Trays, or PacksKNA · Traditional | 08/26/1997SE |
| K971465 | National Medical Halthcare Custom Ophthalmic Kits or TraysHOY · Traditional | 06/04/1997SE |
| K971317 | National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional | 05/08/1997SE |
| K962254 | NHMC Urethral Catheterization TrayFCM · Traditional | 07/29/1996SE |
| K960523 | NHMC Dressing TrayEFQ · Traditional | 04/04/1996SE |
| K960566 | NHMC Foley Catheterization TrayFCM · Traditional | 02/29/1996SE |
Questions and answers
When was NHMC Irrigation Tray cleared by the FDA?
NHMC Irrigation Tray (K962670) received a 510(k) decision of Substantially Equivalent on August 14, 1996, 36 days after the submission was received.
What is the product code of K962670?
The FDA product code is LJH – System, Irrigation, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.