The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Disposable Brain Biopsy Needle 2.0.
| Device ID | K220897 |
| 510k Number | K220897 |
| Device Name: | Disposable Brain Biopsy Needle 2.0 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Contact | Christian G. H. Quass |
| Correspondent | Christian G. H. Quass PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-08-17 |