Product code MJG
- Device name
- Device, Percutaneous, Biopsy
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080674 | PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM | PAJUNK GmbH Medizintechnologie | 2008-05-09 |
| K070836 | EXICLIP EXCS-M | Clevex, Inc. | 2007-04-20 |
| K983647 | ECHO-COAT ULTRASOUND NEEDLES | Sts Biopolymers | 1999-01-20 |
| K955683 | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY | Contour Fabricators of Florida, Inc. | 1996-02-01 |
| K933324 | SKIN BIOPSY DEVICE | Nhr, Inc. | 1994-03-31 |
| K925870 | SPACER | Bip USA, Inc. | 1993-05-19 |
| K922919 | DYNACYT BIOPSY ASPIRATION DEVICE | Buckman Co., Inc. | 1993-03-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033860016883 | BIOPSYBELL SRL | BIOPSYBELL SRL | 2022-06-09 |
| 08052440104666 | PaliumNeedle | M.D.L. S.R.L. | 2017-04-13 |
| 08032986358013 | FastCutS | M.D.L. S.R.L. | 2017-03-20 |
| 08032986357436 | EasyLock | M.D.L. S.R.L. | 2017-03-14 |
| 08052440106271 | Intro | M.D.L. S.R.L. | 2017-03-14 |
| 08052440106363 | Intro | M.D.L. S.R.L. | 2017-03-14 |
| 08052440106356 | Intro | M.D.L. S.R.L. | 2017-03-14 |
| 08032986351427 | FastCutM | M.D.L. S.R.L. | 2017-02-21 |
| 08032986351533 | FastCutM | M.D.L. S.R.L. | 2017-02-21 |
| 08052440106264 | Intro | M.D.L. S.R.L. | 2017-02-20 |
| 08052440106332 | Intro | M.D.L. S.R.L. | 2017-02-20 |
| 08052440106349 | Intro | M.D.L. S.R.L. | 2017-02-20 |
| 08052440103539 | Intro | M.D.L. S.R.L. | 2017-02-20 |
| 08052440106387 | Intro | M.D.L. S.R.L. | 2017-02-20 |
| 08052440106370 | Intro | M.D.L. S.R.L. | 2017-01-05 |
| 08052440106394 | Intro | M.D.L. S.R.L. | 2017-01-05 |
| 08052440106561 | FastCutP | M.D.L. S.R.L. | 2017-01-05 |
| 08052440104734 | PaliumNeedle | M.D.L. S.R.L. | 2017-01-05 |
| 08052440104710 | PaliumNeedle | M.D.L. S.R.L. | 2017-01-05 |
| 08052440104659 | PaliumNeedle | M.D.L. S.R.L. | 2017-01-05 |
| 08052440104635 | PaliumNeedle | M.D.L. S.R.L. | 2017-01-05 |
| 08052440104628 | PaliumNeedle | M.D.L. S.R.L. | 2017-01-05 |
| 08052440104567 | PaliumNeedle | M.D.L. S.R.L. | 2017-01-05 |
| 08052440104550 | PaliumNeedle | M.D.L. S.R.L. | 2017-01-05 |
| 08052440101283 | PaliumNeedle | M.D.L. S.R.L. | 2017-01-05 |
| 08052440105663 | HandCut | M.D.L. S.R.L. | 2017-01-04 |
| 08052440105724 | HandCut | M.D.L. S.R.L. | 2017-01-04 |
| 08052440105748 | HandCut | M.D.L. S.R.L. | 2017-01-04 |
| 08032986359102 | HandCut | M.D.L. S.R.L. | 2017-01-04 |
| 07613327115987 | AccuMark | STRYKER CORPORATION | 2016-09-23 |