510(k) · Cleared
Recalled · Class II · 2017EM ENT Navigated Suctions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Apr 7, 2016 as substantially equivalent to K001284 (Medtronic Surgical Navigation Technologies, 2000) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Apr 7, 2016
- Review
- 115 days
- Class
- Class II
- Product code
- PGW
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001284 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- This deviceK153555 EM ENT Navigated SuctionsMedtronic Navigation, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK180948 TruDi NAV Suction InstrumentsAcclarent, Inc. · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K180948TruDi NAV Suction InstrumentsAcclarent, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| 0 (this device) | K153555 | EM ENT Navigated Suctions | Medtronic Navigation, Inc. | 2016 | — |
| +1 | K180948 | TruDi NAV Suction Instruments | Acclarent, Inc. | 2018 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGW device
- #1 K261540 Cube 4D Navigation System, VirtuEye Proscore 12.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking SystemSummary page 7…code: LRC Regulation: 21CFR 874.4420) Applicable a StealthStation® GoldenEye™ Micro-Magnetic Tracking K001284 06/12/2000 System Option StealthStation® System Update K050… | 2000 |
| * | K050438 | Stealthstation System UpdateSummary page 7…o-Magnetic Tracking K001284 06/12/2000 System Option StealthStation® System Update K050438 06/02/2005 a The Class I Medtronic ENT suction devices were released to market on June 6, 1997. They wer… | 2005 |
| * | — | Manual Surgical Instruments (non-navigated), Class I (product code: LRC Regulation… Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180948 | TruDi NAV Suction Instruments | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2017 | Class II | Z-3053-2017 | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| Jun 29, 2017 | Class II | Z-3055-2017 | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| Jun 29, 2017 | Class II | Z-3056-2017 | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| Jun 29, 2017 | Class II | Z-3058-2017 | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| Jun 29, 2017 | Class II | Z-3051-2017 | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| Jun 29, 2017 | Class II | Z-3057-2017 | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| Jun 29, 2017 | Class II | Z-3054-2017 | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| Jun 29, 2017 | Class II | Z-3052-2017 | Device Design | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PGW devicesPGW Ear, Nose, And Throat Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PGW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGW
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGW
220in 2025
MAUDE reports naming product code PGW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 116 | 0 | 7 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 9 | 115 | 0 | 33 |
| 2017 | 4 | 125 | 0 | 42 |
| 2018 | 2 | — | 0 | 96 |
| 2019 | 1 | — | 3 | 247 |
| 2020 | 8 | 100 | 0 | 161 |
| 2021 | 1 | — | 1 | 190 |
| 2022 | 2 | — | 0 | 166 |
| 2023 | 2 | — | 1 | 200 |
| 2024 | 0 | — | 0 | 274 |
| 2025 | 1 | — | 1 | 220 |
| 2026 | 3 | 65 | 0 | — |
What is it indicated for?
EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on patient anatomy relative to a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The EM ENT instruments are indicated for use in ENT procedures such as: •CSF leak repairs related to ENT procedure •Intranasal procedures…
Read the full statement (121 words)
EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on patient anatomy relative to a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The EM ENT instruments are indicated for use in ENT procedures such as:
•CSF leak repairs related to ENT procedure
•Intranasal procedures
•Orbital decompression procedures
•Polyposis procedures
•Endoscopic dacryocystorhinostomy
•Sinus procedures, such as maxillary antrostomies
•Ethmoidectomies
•Sphenoidotomies/sphenoid explorations
•Turbinate resections and frontal sinusotomies
The EM ENT instruments can also be used in the ENT surgical approach for the following procedures:
•Pituitary tumor removal
•Skull base procedures
•Transsphenoidal procedures
•Optic nerve decompression procedures
•Encephalocele procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153555: EM ENT Navigated Suctions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153555
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026