Panels › Gastroenterology, Urology › Product code FCG · Class 2
Biopsy Needle
Regulation 876.1075
0510(k)s in 12 months (133 all time)
0recalls in 12 months (54 all time)
51recalls that name a 510(k)
Top companies in FCG
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 5 | 24 |
| Bard Peripheral Vascular Inc | 0 | 8 |
| Cook Ireland, Ltd. | 7 | 0 |
| Medi-Globe Corp. | 7 | 0 |
| Olympus Medical Systems Corp. | 7 | 0 |
| Wilson-Cook Medical, Inc. | 5 | 1 |
| Aomori Olympus Co., Ltd. | 0 | 5 |
| Medtronic | 0 | 5 |
| H.S. Hospital Service S.R.L. | 4 | 0 |
| H.S. Hospital Services S.P.A. | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with ethylene oxide
gas . UPN for inner pouch M001434500
Indicated for use endoscopically or percut Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN MOO1434521, Sterilized with ethylene oxide gas. UPN for inner pouch M001434520.
Indicated for use endoscopically or percut Terminated |
FCG | K040893 |
| May 31, 2006 | Bard Peripheral Vascular Inc Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687.
The Bard TruGuide Coaxial Biopsy Needle is a three-part devic Terminated |
FCG | K915801 K936194 |
| Oct 31, 2003 | Wilson-Cook Medical Inc EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum E Terminated |
FCG | K013356 |
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