Home / Device Classification / FGO

FGO — Dislodger, Stone, Flexible Class II

FDA Device Classification

FDA product code FGO covers "Dislodger, Stone, Flexible", a Class II medical device regulated under 21 CFR 876.4680. Submissions are reviewed by the Gastroenterology, Urology panel. At least 19 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FGO
Device Class
Class II
Regulation Number
876.4680
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K001563scion cardiovascularSCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SETNovember 22, 2000
K970121boston scientificSTONE DISLODGER, BASKETApril 2, 1997
K963750boston scientificRETRIEVAL SNARENovember 22, 1996
K962676united states endoscopy groupDISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEOctober 4, 1996
K951309boston scientificSTONE DISLODGER, BASKETMay 17, 1995
K933261surgitekGRASPING FORCEPSJanuary 11, 1994
K934598annex medicalGRASPING FORCEPS OR RETRIEVAL FORCEPSJanuary 7, 1994
K921295critikon companyINTRAVENOUS CATHETERS MODIFICATIONSMay 17, 1993
K922542surgitekGRASPING FORCEPSAugust 19, 1992
K914110annex medicalGRASPING FORCEPSFebruary 28, 1992
K914111annex medicalMETAL URETERAL BASKET STONE DISLODGER, HELICALFebruary 28, 1992
K914112annex medicalMETAL URETERAL BASKET STONE DISLODGER, FLAT WIREFebruary 28, 1992
K896322c.n. technocratsCN GAURD, STERILE LATEX SURGICAL GLOVESJuly 12, 1990
K895080jet far industriesSURGICAL GLOVESJanuary 24, 1990
K893522thai fuji latex coSURGEON'S GLOVESJanuary 22, 1990
K885168boston scientificRUBENSTEIN URETERAL STONE FRAGMENT BRUSHSeptember 8, 1989
K891253northgate researchUROLOGICAL GRASPING FORCEPSMarch 22, 1989
K891252northgate researchUROLOGICAL LOOP RETRIEVERSMarch 22, 1989
K771302v. mueller o.v. baxter healthcarePFISTER-SCHWARTZ STONE RETRIEVERAugust 2, 1977

FDA data resources