Panels › General, Plastic Surgery › Product code MJG · Class 1
Device, Percutaneous, Biopsy
Regulation 878.4800
0510(k)s in 12 months (7 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in MJG
| Company | 510(k)s | Recalls |
|---|---|---|
| Bip USA, Inc. | 1 | 0 |
| Buckman Co., Inc. | 1 | 0 |
| Clevex, Inc. | 1 | 0 |
| Contour Fabricators of Florida, Inc. | 1 | 0 |
| Cook Incorporated | 0 | 1 |
| M.D.L. S.r.l. | 0 | 1 |
| Medical Device Technologies, Inc. | 0 | 1 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 1 |
| Nhr, Inc. | 1 | 0 |
| PAJUNK GmbH Medizintechnologie | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits, labeled as:
BIOPSY TRAY-LF, Pack Number DYNDH1229 Open, Classified |
MJG | None listed |
| Apr 12, 2024 | Cook Incorporated Chiba Biopsy Needle - Used for aspiration biopsy.
REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN):
1) DCHN-18-10.0 G01559
2) DCHN-18-10.0-U G05040
3) DCHN-18-15.0 G00850
4) DCHN-22-10.0 G00852
5) DCH Open, Classified |
MJG | None listed |
| Aug 5, 2021 | M.D.L. S.r.l. General Manual surgical instrument Terminated |
MJG | None listed |
| Oct 8, 2010 | Medical Device Technologies, Inc. Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samp Terminated |
MJG | K982960 |
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