K080674 is an FDA 510(k) clearance for the PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM. This device is classified as a Device, Percutaneous, Biopsy (Class I - General Controls, product code MJG).
Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on May 9, 2008, 60 days after receiving the submission on March 10, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K080674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2008 |
| Decision Date | May 09, 2008 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MJG — Device, Percutaneous, Biopsy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |