The following data is part of a premarket notification filed by 7d Surgical Inc. with the FDA for 7d Surgical System Cranial Biopsy And Ventricular Catheter Placement Application.
| Device ID | K192945 |
| 510k Number | K192945 |
| Device Name: | 7D Surgical System Cranial Biopsy And Ventricular Catheter Placement Application |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | 7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto, CA M3b 2r7 |
| Contact | Daniel Zisind |
| Correspondent | Daniel Zisind 7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto, CA M3b 2r7 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-18 |
| Decision Date | 2019-11-27 |
| Summary: | summary |