SNT DISPOSABLE BIOPSY NEEDLE— 510(k) K971247
Substantially EquivalentSurgical Navigation Technologies, Inc.
FDA 510(k) clearance K971247 for SNT DISPOSABLE BIOPSY NEEDLE, Substantially Equivalent on 1997-06-16. Applicant: Surgical Navigation Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Navigation Technologies, Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Broomfield, CO, US
Recent devices under product code HAW
view allMore clearances from Surgical Navigation Technologies, Inc.
view allAdverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K971247
K-number listed on FDA's recall record- Z-0657-2020 — Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
- Z-0658-2020 — Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
- Z-0659-2020 — Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
- Z-2324-2015 — 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 Needle is intended to be used for stereotaxy biopsy of brain tissue.
- Z-2325-2015 — 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. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971247.
Data sourced from openFDA. This site is unofficial and independent of the FDA.