FDA 510(k) Applications Submitted by KAREN E PETERSON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K102003 |
07/15/2010 |
XPRESS BALLOON DEVICE |
Entellus Medical, Inc. |
| K163609 |
12/22/2016 |
Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) |
PALL INTERNATIONAL SARL |
| K153434 |
11/27/2015 |
Pall-Aquasafe Water Filter |
PALL INTERNATIONAL, SARL |
| K110158 |
01/19/2011 |
ILLUMINATING SINUS SEEKER |
Entellus Medical, Inc. |
| K130503 |
02/27/2013 |
PATHASSIST LED LIGHT FIBER |
Entellus Medical, Inc. |
| K110739 |
03/17/2011 |
ENTELLUS MEDICAL SINUS GUIDEWIRE |
Entellus Medical, Inc. |
| K021160 |
04/11/2002 |
DERMMATRIX SURGICAL MESH |
CARBON MEDICAL TECHNOLOGIES, INC. |
| K121174 |
04/17/2012 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
| K001807 |
06/15/2000 |
TISSUE MARKER |
ADVANCED UROSCIENCE, INC. |
| K111763 |
06/23/2011 |
PATHASSIST LIGHT FIBER |
Entellus Medical, Inc. |
| K002323 |
06/27/2000 |
ADVANCED UROSCIENCE INJECTION NEEDLE |
ADVANCED UROSCIENCE, INC. |
| K121943 |
07/03/2012 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
| K132440 |
08/06/2013 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
| K982890 |
08/17/1998 |
ADVANCED UROSCIENCE INJECTION NEEDLE |
ADVANCED UROSCIENCE, INC. |
| K002573 |
08/18/2000 |
ADVANCED UROSCIENCE INNERSHEATH |
ADVANCED UROSCIENCE, INC. |
| K102366 |
08/20/2010 |
FINESS ENDOSCOPE |
Entellus Medical, Inc. |
| K112506 |
08/30/2011 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
| K993459 |
10/13/1999 |
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
ADVANCED UROSCIENCE, INC. |
| K103213 |
11/01/2010 |
FINESS ENDOSCOPE STERILIZATION TRAY |
Entellus Medical, Inc. |
| K964154 |
10/16/1996 |
SEGUE INFUSION CATHETER |
INTERVENTIONAL INNOVATIONS CORP. |
| K222032 |
07/11/2022 |
NEUROMARK System |
Neurent Medical |
| K142252 |
08/14/2014 |
XprESS Multi-Sinus Dilation Tool |
ENTELLUS MEDICAL, INC. |
| K152434 |
08/27/2015 |
XprESS Multi-Sinus Dilation System |
ENTELLUS MEDICAL, INC. |
| K152435 |
08/27/2015 |
PassAssist LED Light Fiber |
ENTELLUS MEDICAL, INC. |
| K192661 |
09/25/2019 |
LATERA Absorbable Nasal Implant System |
Entellus Medical, Inc. (Aka Stryker ENT) |
| K163509 |
12/15/2016 |
XprESS ENT Dilation System |
Entellus Medical, Inc. |
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