FDA product code MJG: Device, Percutaneous, Biopsy
MJG is the FDA product code for device, percutaneous, biopsy. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under MJG, from 7 different applicants. The average 510(k) review took 137 days (median 96). FDA has posted 4 recalls for MJG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Percutaneous, Biopsy |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MJG clearance
Top MJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| PAJUNK GmbH Medizintechnologie | 1 | 2008-05-09 |
| Clevex, Inc. | 1 | 2007-04-20 |
| Sts Biopolymers | 1 | 1999-01-20 |
| Contour Fabricators of Florida, Inc. | 1 | 1996-02-01 |
| Nhr, Inc. | 1 | 1994-03-31 |
2 more applicants have MJG clearances. See the full list in Caduvo.
Most recent MJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080674 | PAJUNK GmbH Medizintechnologie | PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM | 2008-05-09 | 60 |
| K070836 | Clevex, Inc. | EXICLIP EXCS-M | 2007-04-20 | 24 |
| K983647 | Sts Biopolymers | ECHO-COAT ULTRASOUND NEEDLES | 1999-01-20 | 96 |
| K955683 | Contour Fabricators of Florida, Inc. | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY | 1996-02-01 | 49 |
| K933324 | Nhr, Inc. | SKIN BIOPSY DEVICE | 1994-03-31 | 262 |
Recalls for MJG devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-04-08.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code MJG?
MJG is the FDA product code for device, percutaneous, biopsy. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is MJG?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MJG?
Across 7 cleared submissions the average was 137 days from receipt to decision (median 96).
Which companies have the most MJG clearances?
PAJUNK GmbH Medizintechnologie (1); Clevex, Inc. (1); Sts Biopolymers (1); Contour Fabricators of Florida, Inc. (1); Nhr, Inc. (1).
Have MJG devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code MJG
- Run a recall and safety report across every MJG manufacturer
- Watch product code MJG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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