MJG
7 FDA 510(k) clearances · Product code
96 daysmedian time to decision
287 days90th percentile
7clearances measured
FDA profile
- Official device name
- Device, Percutaneous, Biopsy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1996: 3 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (K080674) | PAJUNK GmbH Medizintechnologie | 2008-05-09 |
| EXICLIP EXCS-M (K070836) | Clevex, Inc. | 2007-04-20 |
| ECHO-COAT ULTRASOUND NEEDLES (K983647) | Sts Biopolymers | 1999-01-20 |
| RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (K955683) | Contour Fabricators of Florida, Inc. | 1996-02-01 |
| SKIN BIOPSY DEVICE (K933324) | Nhr, Inc. | 1994-03-31 |
| SPACER (K925870) | Bip USA, Inc. | 1993-05-19 |
| DYNACYT BIOPSY ASPIRATION DEVICE (K922919) | Buckman Co., Inc. | 1993-03-31 |
Track MJG automatically
Every clearance here is in the API, with alerts when new ones post.