Sterile Fluid Producing Unit #EP550
FDA 510(k) K832040 · American Cystocope Makers, Inc.
510(k) numberK832040
Submission
- Device name
- Sterile Fluid Producing Unit #EP550
- Applicant
- American Cystocope Makers, Inc.
Mchenry, IL, US - Received
- June 24, 1983
- Decision date
- September 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K812637 | Acmi Bipolar Hemostatic SourceGEI · Traditional | 10/26/1981SE |
| K811218 | Acmi Aspirator Kit #8808EOQ · Traditional | 07/01/1981SE |
| K803214 | Acmi Bipolar Hemostatic ElectrodeFEH · Traditional | 01/15/1981SE |
| K791182 | Acmi Rigi-Flex NephorscopeFGA · Traditional | 07/30/1979SE |
| K770754 | Duodenoscope, Molel TX-6FOG · Traditional | 04/28/1977SE |
| K760822 | Model TX-8 PanendoscopeFAK · Traditional | 10/21/1976SE |
| K760452 | Colonoscope, 2-CHANNEL Log (Acmi TX-92)FDF · Traditional | 08/30/1976SE |
| K760451 | Air Water Source (Acmi Model 710)OCX · Traditional | 08/30/1976SE |
Questions and answers
When was Sterile Fluid Producing Unit #EP550 cleared by the FDA?
Sterile Fluid Producing Unit #EP550 (K832040) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 97 days after the submission was received.
What is the product code of K832040?
The FDA product code is LJH – System, Irrigation, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.