510(k) K003190 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
EN BLOC BIOPSY SYSTEM
| Applicant | Neothermia Corp., Natick MA, US |
| Decision | Substantially Equivalent, Jun 11, 2001 |
| Received | Oct 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-110: 5 Pack 10mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
900-112: 5 Pack 12mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-112: 5 Pack 12mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-112BT: 5 Pack 12mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
900-115: 5 Pack 15mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-115: 5 Pack 15mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-115BT: 5 Pack 15mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
900-120: 5 Pack 20mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-120: 5 Pack 20mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-120BT: 5 Pack 20mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati Terminated |
KNW | None listed |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
900-130: 5 Pack 30mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.