510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Entellus Medical, Inc.

Maple Grove, MN, US

Entellus Medical, Inc. appears in FDA device records in Maple Grove, MN. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
27
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 27 510(k) clearances for Entellus Medical, Inc. between 2008 and 2022. The busiest year on record is 2011, with 6. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Entellus Medical, Inc., by decision year
YearClearances
20083
20091
20102
20116
20125
20133
20142
20152
20172
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220027Audion ET dilation systemPNZSubstantially Equivalent
K163509XprESS ENT Dilation SystemPNZSubstantially Equivalent
K163435Entellus Medical Reinforced Anesthesia NeedleBSPSubstantially Equivalent
K152435PassAssist LED Light FiberLRCSubstantially Equivalent
K152434XprESS Multi-Sinus Dilation SystemLRCSubstantially Equivalent
K142252XprESS Multi-Sinus Dilation ToolLRCSubstantially Equivalent
K141916PATHASSIST LED LIGHT FIBERLRCSubstantially Equivalent
K133563PATHASSIST LIGHT SEEKERLRCSubstantially Equivalent
K132440XPRESS MULTI-SINUS DILATION TOOLLRCSubstantially Equivalent
K130503PATHASSIST LED LIGHT FIBERLRCSubstantially Equivalent
K121943XPRESS MULTI-SINUS DILATION TOOLLRCSubstantially Equivalent
K121174XPRESS MULTI-SINUS DILATION TOOLLRCSubstantially Equivalent
K120962PATHASSIST LIGHT FIBERLRCSubstantially Equivalent
K120735PATHASSIT LIGHT SEEKERLRCSubstantially Equivalent
K113522PATHASSIST LIGHT SEEKERLRCSubstantially Equivalent
K112506XPRESS MULTI-SINUS DILATION TOOLLRCSubstantially Equivalent
K111763PATHASSIST LIGHT FIBERLRCSubstantially Equivalent
K110739ENTELLUS MEDICAL SINUS GUIDEWIRELRCSubstantially Equivalent
K110158ILLUMINATING SINUS SEEKERLRCSubstantially Equivalent
K102366FINESS ENDOSCOPEEOBSubstantially Equivalent
K103213FINESS ENDOSCOPE STERILIZATION TRAYKCTSubstantially Equivalent
K102003XPRESS BALLOON DEVICELRCSubstantially Equivalent
K093007ENTELLUS MEDICAL BALLOON DEVICELRCSubstantially Equivalent
K091681FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)LRCSubstantially Equivalent
K082569ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECEEOBSubstantially Equivalent
K081542MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEMLRCSubstantially Equivalent
K072302ENTELLUS MEDICAL RS-SERIES SYSTEMLRCSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain