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GAL — Suture, Absorbable, Natural Class II

FDA Device Classification

Classification Details

Product Code
GAL
Device Class
Class II
Regulation Number
878.4830
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K142656covidienSurgical Gut SutureJanuary 29, 2015
K072930demetechDEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTApril 30, 2008
K042287united medical industries co.UNIPLAIN & UNICHROMSeptember 7, 2005
K042897ethicon endo-surgeryAUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGENovember 19, 2004
K030227suturtek incorporatedSUTURTEK FASTCLOSE SUTURING DEVICEMarch 17, 2003
K020597serral, s.a. de c.vSERRALGUTAugust 14, 2002
K021043gramsmedGRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICJune 21, 2002
K011105qrc consultingSUTURTEK FASTCLOSE FASCIA CLOSURE DEVICEMay 30, 2001
K001299cp medicalPLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USPJune 23, 2000
K000542arc medical supplies (beijing) coPLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USPApril 28, 2000
K993695hysterxLIGA-LOOP SUTURE APPLICATORApril 13, 2000
K994002trading consultants and distributors intlPLAIN/CHROMIC CATGUTFebruary 4, 2000
K982646myco medical suppliesAILEE SUTURES AND AILEE NEEDLESJune 2, 1999
K991223aesculapABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAApril 30, 1999
K961931r. k. medical l. l. cPLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USPJuly 29, 1996
K943218suturesCHROMIC CATGUTDecember 5, 1994
K943217suturesPLAIN CATGUTDecember 5, 1994
K930738deknatelSURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETCJuly 26, 1994
K930416united states surgical, a division of tyco healthcSURGICAL SUTURE PACKAGE INSERTSApril 28, 1994
K931919surgimetrics internationalCATGUT SUTURE CHROMICMarch 3, 1994