Panels › Gastroenterology, Urology › Product code KNY · Class 2
Accessories, Catheter, G-U
Regulation 876.5130
1510(k)s in 12 months (65 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in KNY
| Company | 510(k)s | Recalls |
|---|---|---|
| Percutaneous Systems, Inc. | 5 | 0 |
| Lake Region Mfg., Inc. | 3 | 0 |
| Promepla Sam | 3 | 0 |
| Solace Therapeutics | 3 | 0 |
| Avail Medical Products, Inc. | 2 | 0 |
| Boston Scientific Corp | 2 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 2 | 0 |
| Kit Pak, Inc. | 2 | 0 |
| Medical Device Technologies, Inc. | 2 | 0 |
| Olympus Corporation of the Americas | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2024 | Olympus Corporation of the Americas Brand Name: UroPass Ureteral Access Sheaths
Product Name: Ureteral Access Sheaths
Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246B Open, Classified |
KNY | K051593 |
| Aug 14, 2023 | Olympus Corporation of the Americas UroPass Ureteral Access Sheaths, 5 pieces/box Open, Classified |
KNY | K051593 |
| May 26, 2011 | Gyrus Acmi, Incorporated Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA
Ureteral guidewires are used Terminated |
KNY | None listed |
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