Home / Companies / Summit Medical, LLC

Summit Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
14
Inspections
12
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1171-2023Class IISummit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.January 13, 2023
Z-0435-2016Class IIAbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-74September 3, 2015
Z-1731-2014Class IIArmstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by EthylMay 12, 2014
Z-1319-2013Class IISummit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 NoMarch 27, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K180528InstruSafe(R) Sterilization ContainerNovember 16, 2018
K173110GRAFTSITEMay 18, 2018
K170388ANCHORMAN Tibial Ligament Fixation DeviceJuly 25, 2017
K162046MINNE TIES MMF Suture SystemApril 11, 2017
K151166Instru-Safe Instrument Protection SystemAugust 18, 2015
K150540Instru-Safe Instrument Protection SystemJune 22, 2015
K142768Instru-Safe Instrument Protection SystemMay 29, 2015
K142630Instru-Safe Instrument Protection SystemDecember 23, 2014
K141513INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMDecember 15, 2014
K140289INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMJune 27, 2014
K133015INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMMarch 13, 2014
K024097SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14February 14, 2003
K022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMIOctober 25, 2002
K022489SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514October 9, 2002