510(k) K153555 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
EM ENT Navigated Suctions
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Apr 7, 2016 |
| Received | Dec 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
The suction devices are part of a family of reusable ENT instrument Terminated |
PGW | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
The suction devices are part of a family of reusable ENT instrumen Terminated |
PGW | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
The suction devices are part of a family of reusable ENT instrume Terminated |
PGW | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
The suction devices are part of a family of reusable ENT instrument Terminated |
PGW | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The Terminated |
PGW | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). T Terminated |
PGW | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
Th Terminated |
PGW | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 Terminated |
PGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.