510(k) K971247 ยท HAW Neurological Stereotaxic Instrument
SNT DISPOSABLE BIOPSY NEEDLE
| Applicant | Surgical Navigation Technologies, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Jun 16, 1997 |
| Received | Apr 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971247
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly Open, Classified |
HAW | None listed |
| Oct 30, 2019 | Medtronic Navigation, Inc. Passive Biopsy Needle Kit, UDI: 00643169030121
and 00643169702943 Open, Classified |
HAW | None listed |
| Oct 30, 2019 | Medtronic Navigation, Inc. Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 Open, Classified |
HAW | None listed |
| Oct 30, 2019 | Medtronic Navigation, Inc. Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 Open, Classified |
HAW | None listed |
| Aug 3, 2015 | Medtronic Navigation, Inc. Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit.
The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Nee Terminated |
HAW | None listed |
| Aug 3, 2015 | Medtronic Navigation, Inc. Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit.
The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. Th Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.