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GDM — Needle, Aspiration And Injection, Reusable Class I

FDA Device Classification

Classification Details

Product Code
GDM
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K071732stemcor systemsMARROWMINERSeptember 24, 2007
K971114bioaccessBIOACCESS MARROW HARVEST SYSTEMJune 3, 1997
K953082baxter healthcareILIAC CREST BONE MARROW ASPIRATION NEEDLESeptember 22, 1995
K953064bioaccessBIOACCESS MARROW HARVEST SYSTEMAugust 7, 1995
K936207gerard medicalENDO-NEEDLE INSTRUMENTJune 16, 1994
K930160symbiosisILLINOIS STERNAL/ILIAC ASPIRATION NEEDLEJuly 6, 1993
K923872straumannBONE MARROW BIOPSY SYSTEMDecember 15, 1992
K915572bd becton dickinson vacutainer systems preanalyticBECTON DICKINSON MODIFIED MENGHINI NEEDLEFebruary 3, 1992
K904667olympusNA NEEDLESDecember 12, 1990
K903748downs surgicalISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-VOctober 31, 1990
K903747downs surgicalISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-UOctober 31, 1990
K903749downs surgicalISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-UOctober 31, 1990
K903750downs surgicalISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-EOctober 31, 1990
K902177manan medical productsMANAN BONE BIOPSY NEEDLESeptember 5, 1990
K901995mill-rose laboratoryPLEURA BIOPSY DEVICEJuly 10, 1990
K895752magnum diamondDIAMOND BLADE SURGICAL KNIVESOctober 17, 1989
K895594go medical industries pty.SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLEOctober 6, 1989
K895551a and a medicalROCKET BONE MARROW NEEDLEOctober 6, 1989
K890722american design groupADG BONE BIOPSY SYSTEMSeptember 21, 1989
K891537dlpCORE BIOPSY NEEDLE, CATALOG CODE #54006April 18, 1989