# K133665: Malleable Suction Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Mar 13, 2014 after 104 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001284 (2000). 2 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System, Medtronic Surgical Navigation Technologies (2000) Summary page 3.
- K130608: Quadcut, Medtronic Navigation, Inc. (2013) Summary page 3.
- (no number) Medtronic ENT Suction Device: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K050548: Contour Midface Opposing Uni-Directional Threads, Surgical Specialties Corp (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell (2014), 13 descendants of its own
- K171661: Scopis Extended Instrument Set EM (2017), 3 descendants of its own
- K161697: Acclarent NavWire Sinus Navigation Guidewire (2016), 3 descendants of its own
- K160369: GuideWire (2016), 3 descendants of its own
- K161940: Guidewire 0.6 Single Use (2016), 2 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K133665
Methodology: https://510kreport.com/methodology