Ear, Nose, And Throat Stereotaxic Instrument
Regulation 882.4560
3510(k)s in 12 months (38 all time)
1recalls in 12 months (17 all time)
17recalls that name a 510(k)
Top companies in PGW
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Navigation, Inc. | 6 | 8 |
| Acclarent, Inc. | 8 | 5 |
| Fiagon GmbH | 11 | 0 |
| Biosense Webster | 2 | 0 |
| Scopis GmbH | 2 | 0 |
| Stryker Corporation | 2 | 0 |
| Stryker Ent | 2 | 0 |
| Brainlab AG | 1 | 0 |
| Claronav | 1 | 0 |
| Integra LifeSciences Corp. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2025 | Integra LifeSciences Corp. (NeuroSciences) TruDi Navigation System - Multi Instrument Adapter; -
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; Open, Classified |
PGW | K231862 |
| Aug 5, 2024 | Integra LifeSciences Corp. TruDi NAV Suction, 0 Degrees;
Model/Catalog Number: TDNS000Z.
TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skul Open, Classified |
PGW | K180948 |
| May 23, 2024 | Stryker Leibinger GmbH & Co. KG 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highl Open, Classified |
PGW | K221098 |
| Oct 20, 2023 | Acclarent, Inc. TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 Open, Classified |
PGW | K192397 |
| Nov 12, 2021 | Acclarent, Inc. TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z Open, Classified |
PGW | K180948 |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 Terminated |
PGW | K180948 |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 Terminated |
PGW | K180948 |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 Terminated |
PGW | K180948 |
| 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 | K153555 |
| 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 | K153555 |
| 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 | K153555 |
| 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 | K153555 |
| 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 | K153555 |
| 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 | K153555 |
| 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 | K153555 |
| 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 | K153555 |
| Apr 19, 2017 | Stryker Instruments Div. of Stryker Corporation Stryker PROFESS Registration Kit.
The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer- Terminated |
PGW | K141551 |
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