The following data is part of a premarket notification filed by Gistlstrasse with the FDA for Aneurysm Clips.
| Device ID | K013136 |
| 510k Number | K013136 |
| Device Name: | ANEURYSM CLIPS |
| Classification | Clip, Aneurysm |
| Applicant | GISTLSTRASSE GISTLSTRASSE 99 Pullach, DE 82049 |
| Contact | Dieter Von Seppelin |
| Correspondent | Dieter Von Seppelin GISTLSTRASSE GISTLSTRASSE 99 Pullach, DE 82049 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-19 |
| Decision Date | 2001-11-26 |
| Summary: | summary |