# K153555: EM ENT Navigated Suctions

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Apr 7, 2016 after 115 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001284 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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 7.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 7.
- (no number) Manual Surgical Instruments (non-navigated), Class I (product code: LRC Regulation: 21CFR 874.4420): named in the summary without a submission number

## Most influential descendants
- K180948: TruDi NAV Suction Instruments (2018), 0 descendants of its own

## Recalls of this device
- Jun 29, 2017 · Class II · Z-3053-2017: 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: 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: 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: 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: 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: 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: 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: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.

## Indications for use
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

Source page: https://510kreport.com/device/K153555
Methodology: https://510kreport.com/methodology