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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K180708
Device Name Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
Applicant
Xeridiem Medical Devices, A Spectrum Plastics Group Company
4700 S. Overland Dr.
Tucson,  AZ  85714
Applicant Contact Steve Murray
Correspondent
Xeridiem Medical Devices, A Spectrum Plastics Group Company
4700 S. Overland Dr.
Tucson,  AZ  85714
Correspondent Contact Steve Murray
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
KNT  
Date Received03/19/2018
Decision Date 10/18/2018
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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