GDJ — Clamp, Surgical, General & Plastic Surgery Class I

FDA Device Classification

FDA product code GDJ covers "Clamp, Surgical, General & Plastic Surgery", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification details

Product Code
GDJ
Device Class
Class I
Regulation Number
878.4800
Submission Type
510(k) Exempt
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K153358Standard BariatricsStandard ClampMay 2, 2016
K930315Thomasville Medical AssocTHORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCEFeb 4, 1994
K924223Mar-MedMAR-MED LIVER STRAPMar 18, 1993
K922659Miltex InstrumentGENERAL SURGERY CLAMP AND NEEDLE HOLDERJul 21, 1992
K914913Ideal MedicalGRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYSTDec 31, 1991
K900956Solos EndoscopyGS-7100 CHOLANGIOGRAM CLAMP, 5MMApr 18, 1990
K901107United States Surgical, A Division Of Tyco HealthcMODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATICApr 9, 1990
K895726Applied Medical TechnologiesVESSEL OCCLUDEROct 24, 1989
K895591Key SurgicalSILICONE INSTRUMENT SHODSOct 20, 1989
K882169Henley IntlSURGICAL DUCT CLAMP (VINE)Jun 17, 1988
K881741Stuart-LeeSTUART LEE CLIPJun 3, 1988
K881084Med-Dex IntlUTILITY CLAMPMar 25, 1988
K874428United States Surgical, A Division Of Tyco HealthcAUTO SUTURE PURSE STRING APPLIER*Dec 2, 1987
K855144DlpTOURIQUET KIT WITH SNAREFeb 5, 1986
K853583Modern Medical ProductsMODERN MEDICAL PRODUCTS TOWEL CLAMPSep 16, 1985
K852724Huxley InstrumentBACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420Jul 15, 1985
K851774Artiberia17-900 TO 17-980 VARIOUS TOWEL CLAMPSJun 20, 1985
K843816TalboyTAL-CLIPOct 31, 1984
K812388Berkeley MedevicesSURGICAL PAWSNov 16, 1981
K801660EthiconPROXIMATE * PSD PURSE-STRING DEVICEAug 13, 1980

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.