# Entellus Medical, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 27 (2008–2022): 27 510(k) clearances
- Product codes: LRC (21), EOB (2), PNZ (2), KCT (1), BSP (1)
- Predicates its devices cite: 37 (22 its own); citations of its devices by later devices: 46 (22 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Acclarent, Inc.: 4 (https://510kreport.com/company/acclarent)
- Neometrics, Inc.: 2 (https://510kreport.com/company/neometrics)
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Kyphon, Inc.: 1 (https://510kreport.com/company/kyphon)
- Gyrus Ent LLC: 1 (https://510kreport.com/company/gyrus-ent)
- Exploramed Nc1, Inc.: 1 (https://510kreport.com/company/exploramed-nc1)
- Optim, LLC: 1 (https://510kreport.com/company/optim)
- Advanced Sterilization Products: 1 (https://510kreport.com/company/advanced-sterilization-products)

## Firms that cite its devices most
- Acclarent, Inc.: 5 (https://510kreport.com/company/acclarent)
- 3nt Medical, Ltd.: 4 (https://510kreport.com/company/3nt-medical)
- Fiagon GmbH: 2 (https://510kreport.com/company/fiagon)
- Medtronic Xomed, Inc.: 2 (https://510kreport.com/company/medtronic-xomed)
- Excelent, Inc.: 2 (https://510kreport.com/company/excelent)
- Sinusys Corporation: 2 (https://510kreport.com/company/sinusys)
- Stryker Ent: 2 (https://510kreport.com/company/stryker-ent)
- Covidien, Formerly Valleylab, A Division of Tyco H: 1 (https://510kreport.com/company/covidien-formerly-valleylab-a-division-of-tyco-h)

## Its most-cited devices
- K102003: Xpress Balloon Device (2010), cited by 7
- K163509: XprESS ENT Dilation System (2017), cited by 5
- K121174: Xpress Multi-Sinus Dilation Tool (2012), cited by 3
- K121943: Xpress Multi-Sinus Dilation Tool (2012), cited by 3
- K093007: Entellus Medical Balloon Device (2010), cited by 2
- K142252: XprESS Multi-Sinus Dilation Tool (2014), cited by 2

## Recent decisions
- K220027: Audion ET dilation system (Apr 12, 2022)
- K163509: XprESS ENT Dilation System (Apr 5, 2017)
- K163435: Entellus Medical Reinforced Anesthesia Needle (Apr 5, 2017)
- K152435: PassAssist LED Light Fiber (Nov 20, 2015)
- K152434: XprESS Multi-Sinus Dilation System (Nov 20, 2015)
- K142252: XprESS Multi-Sinus Dilation Tool (Oct 17, 2014)
- K141916: Pathassist Led Light Fiber (Aug 7, 2014)
- K133563: Pathassist Light Seeker (Dec 20, 2013)

Source page: https://510kreport.com/company/entellus-medical