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EMX — Balloon, Epistaxis Class I

FDA Device Classification

Classification Details

Product Code
EMX
Device Class
Class I
Regulation Number
874.4100
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220326hemostasisPosiSep X BAM Hemostat Dressing/Intranasal SplintNovember 14, 2022
K041446les laboratorires brothierNASALCEASEJuly 1, 2004
K000108bhk holdingRAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-May 23, 2000
K993362biomatrixHYLASINEMarch 13, 2000
K983276hydroferaHYDROFERA BACTERISTATIC NASAL DRESSINGSeptember 14, 1999
K982731xomedMEROGEL NASAL DRESSING AND SINUS STENTFebruary 2, 1999
K984069les laboratorires brothierENTAXIS NASAL PACKINGJanuary 25, 1999
K981966michael m. knott, m.dNOSEBLEED NOSECLIPAugust 14, 1998
K973656specialty surgical productsDISPOSABLE SILICONE EPISTAXIS CATHETERNovember 18, 1997
K973085ultracell medical technologiesULTRACELL PACKING WITH SLEEVENovember 18, 1997
K972922interview medical technologyVYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KITOctober 8, 1997
K972459boston medical productsRHINOCELL NASAL PACKINGSAugust 4, 1997
K972078boston medical productsPOST-STOP EPISTAXIS CATHETERJuly 10, 1997
K972076boston medical productsEPI-MAX EPISTAXIS CATHETERJune 26, 1997
K972077boston medical productsEPI-STOP EPISTAXIS CATHETERJune 26, 1997
K971411bentec medicalDISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATJune 3, 1997
K971000invotec internationalEPISTAXIS NASAL PACKMay 14, 1997
K964113m-pact worldwide managementIVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAYNovember 7, 1996
K963856rand scientificRAND NASAL PACKINGOctober 18, 1996
K962133shippert medical technologiesEXPANDACELL INJECTO-PAKAugust 1, 1996