510(k) · Cleared
ClearedMalleable Suction Instruments
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 Mar 13, 2014 as substantially equivalent to K001284 (Medtronic Surgical Navigation Technologies, 2000) and 1 other predicate after a 104-day review. Its family tree reaches back 2 generations to 2000. 14 later devices descend from it.
- Decided
- Mar 13, 2014
- Review
- 104 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001284 (2000). 14 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 1 generation backK130608 QuadcutMedtronic Navigation, Inc. · 2013 · Recalled
- This deviceK133665 Malleable Suction InstrumentsMedtronic Navigation, Inc. · 2014
- Descendant · cites it directly · 13 of its ownK141456 The Fiagon Navigation - Extended Instrument Set Ent…Fiagon GmbH · 2014
- Descendant · 2 generations on · 3 of its ownK171661 Scopis Extended Instrument Set EMScopis GmbH · 2017
- Descendant · 2 generations on · 3 of its ownK161697 Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK160369 GuideWireFiagon GmbH · 2016
- Descendant · 3 generations on · 2 of its ownK161940 Guidewire 0.6 Single UseFiagon GmbH · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH · 2014 · cites it directly13descendants
- K171661Scopis Extended Instrument Set EMScopis GmbH · 2017 · 2 generations on3descendants
- K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. · 2016 · 2 generations on3descendants
- K160369GuideWireFiagon GmbH · 2016 · 2 generations on3descendants
- K161940Guidewire 0.6 Single UseFiagon GmbH · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −1 | K130608 | Quadcut | Medtronic Navigation, Inc. | 2013 | 1 |
| 0 (this device) | K133665 | Malleable Suction Instruments | Medtronic Navigation, Inc. | 2014 | — |
| +1 | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | Fiagon GmbH | 2014 | — |
| +2 | K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017 | — |
| +2 | K161697 | Acclarent NavWire Sinus Navigation Guidewire | Acclarent, Inc. | 2016 | — |
| +2 | K160369 | GuideWire | Fiagon GmbH | 2016 | — |
| +3 | K161940 | Guidewire 0.6 Single Use | Fiagon GmbH | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking SystemSummary page 3…suction comparison and, Dvcwhich references 7/26/20 10 9734309 and 97343 10 - Deies K00 1284 navigation accuracy K050438) com… | 2000 |
| * | K130608 | QuadcutSummary page 3…n Magnetic Tracking System technology Option Medtronic Quadcut K 130608 08/07/20 13 Suction and Navigation Medtronic Letter to RNs… | 2013 |
| Kept off the family tree | K050548 | FDA’s K050548 is Contour Midface Opposing Uni-Directional Threads Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| * | — | Medtronic ENT Suction Device Named without a submission number |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | 2014 | 13 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K141456 (Fiagon GmbH, 2014) has gone furthest, with 13 descendants of its own.
- 8 other devices also cite its predicate K001284.
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. 2014, 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?
The Malleable SuctionTM Instrument is indicated for use in ENT procedures where surgical navigation or image-guided surgery may be necessary to locate and remove fluids, semi-fluid substances, tissue, and bone dust. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and Medtronic ENT software. The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for…
Read the full statement (222 words)
The Malleable SuctionTM Instrument is indicated for use in ENT procedures where surgical navigation or image-guided surgery may be necessary to locate and remove fluids, semi-fluid substances, tissue, and bone dust. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and Medtronic ENT software.
The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereoitactic surgery may be appropriate, and where reference to arigid anatomical structure, such as the skull, can be identified relative to aCT- or MR-based model or digitized landmarks of the anatomy.
The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.
The Malleable SuctionTM Instrument is indicated for use in the following procedures:
* Pituitary tumor removal only ENT procedures
* CSF leak repair only related or from an ENT procedure
* Skull base procedures for ENT access
* Transsphenoidal procedures
* Intranasal procedures
* Optic nerve decompression procedures
* Orbital decompression procedures
* Polyposis procedures
* Endloscopic dacryocystorhinostomy
* Encephalocele procedures
* Sinus procedures, such as maxillary antrostomnies
* Ethmoidectomies
* Sphenoidotomies/sphenoid explorations
* Turbinate resections and frontal sinusotamies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133665: Malleable Suction Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133665
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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