Panels › Gastroenterology, Urology › Product code LJH · Class 2
System, Irrigation, Urological
Regulation 876.5130
2510(k)s in 12 months (30 all time)
0recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in LJH
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 5 | 0 |
| Baxter Healthcare Corp | 1 | 3 |
| Hospira Inc. | 0 | 2 |
| Medical Scientific, Inc. | 2 | 0 |
| Northgate Technologies, Inc. | 2 | 0 |
| American Cystocope Makers, Inc. | 1 | 0 |
| Amsino Intl., Inc. | 1 | 0 |
| Aquintel, Inc. | 1 | 0 |
| B.Braun Medical, Inc. | 1 | 0 |
| Benlan, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | Canadian Hospital Specialties MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 Terminated |
LJH | K010607 |
| Jul 19, 2014 | Stryker Endoscopy Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the eva Terminated |
LJH | K042457 |
| May 16, 2014 | Hospira Inc. LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira
Produc Terminated |
LJH | None listed |
| May 16, 2014 | Hospira Inc. LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira
Pr Terminated |
LJH | None listed |
| Jul 10, 2013 | Baxter Healthcare Corp. Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m)
Usage:
Baxter irrigation sets are intended for the delivery of Terminated |
LJH | K960787 |
| Jul 10, 2013 | Baxter Healthcare Corp. Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m)
Usage:
Baxter irrigation sets are intended for the delivery of Terminated |
LJH | K960787 |
| Jul 10, 2013 | Baxter Healthcare Corp. Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m)
Usage:
Baxter irrigation sets are intended for the delivery of irrigatin Terminated |
LJH | K960787 |
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