Pajunk's Primocut Disposable Biopsy System
FDA 510(k) K080674 · PAJUNK GmbH Medizintechnologie
510(k) numberK080674
Submission
- Device name
- Pajunk's Primocut Disposable Biopsy System
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- March 10, 2008
- Decision date
- May 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJG – Device, Percutaneous, Biopsy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070836 | Exiclip Excs-MMJG · Traditional | Clevex, Inc. | 04/20/2007SE |
| K983647 | Echo-Coat Ultrasound NeedlesMJG · Traditional | Sts Biopolymers | 01/20/1999SE |
| K955683 | RNS Sterile, Disposable Breast Biopsy/Localization TrayMJG · Traditional | Contour Fabricators of Florida, Inc. | 02/01/1996SE |
| K933324 | Skin Biopsy DeviceMJG · Traditional | Nhr, Inc. | 03/31/1994SE |
| K925870 | SpacerMJG · Traditional | Bip USA, Inc. | 05/19/1993SE |
| K922919 | Dynacyt Biopsy Aspiration DeviceMJG · Traditional | Buckman Co., Inc. | 03/31/1993SE |
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Questions and answers
When was Pajunk's Primocut Disposable Biopsy System cleared by the FDA?
Pajunk's Primocut Disposable Biopsy System (K080674) received a 510(k) decision of Substantially Equivalent on May 9, 2008, 60 days after the submission was received.
What is the product code of K080674?
The FDA product code is MJG – Device, Percutaneous, Biopsy, a Class I (low risk) device regulated under 21 CFR 878.4800.