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GCB — Needle, Catheter Class I

FDA Device Classification

Classification Details

Product Code
GCB
Device Class
Class I
Regulation Number
878.4200
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K150800b.braun medicalValved Safety Centesis CatheterNovember 12, 2015
K974146allegiance healthcarePARACENTESIS CATHETER DEVICEJanuary 28, 1998
K930568medical dynamicsADAIR/VERESS NEEDLE INTRODUCER SETJuly 22, 1993
K923028symbiosisTURKEL PNEUMOTHORAX KITAugust 4, 1992
K900374medical dynamicsADAIR/VERESS NEEDLE INTRODUCER SETApril 20, 1990
K854327concord laboratoriesSUBCUTANEOUS TUNNELING NEEDLES & HANDLESNovember 13, 1985
K852428manan manufacturing coMANAN EPIDURAL NEEDLEJune 27, 1985
K780896jelco laboratoriesNEEDLES, DESIGN CHANGE, IV CATHETERSAugust 23, 1978