Gastroenterology, Urology

FFL · Dislodger, Stone, Basket, Ureteral, Metal

Gastroenterology, Urology · 21 CFR 876.4680 · Class 2

Overview

Product CodeFFL
Device NameDislodger, Stone, Basket, Ureteral, Metal
Regulation21 CFR 876.4680
Device ClassClass 2
Review PanelGastroenterology, Urology

Identification

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Cleared Devices (52)

RecordDevice NameApplicantDecision DateDecision
K190492Peralta Stone Removal CatheterCalcula Technologies, Inc.Jul 18, 2019SESE
K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion MedicalSep 19, 2017SESE
K102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510Percutaneous Systems, Inc.May 16, 2011SESE
K082803COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015Percutaneous Systems, Inc.Nov 13, 2008SESE
K052048ACCORDIONPercutaneous Systems, IncorporatedSep 13, 2005SESE
K012581REPROCESSED STONE RETRIEVAL BASKETSSterilmed, Inc.Feb 14, 2002SESE
K972091AMS FOREIGN BODY EXTRATORAmerican Medical Systems, Inc.Aug 29, 1997SESE
K970489COMEG ENDOSCOPY GRASPING FORCEPSComeg EndoscopyMar 19, 1997SESE
K962387OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)Olympus America, Inc.Jul 31, 1996SESE
K961248BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPSC.R. Bard, Inc.May 28, 1996SESE
K955049OLYMPUS FG-45/46-1 GRASPING FORCEPSOlympus America, Inc.Dec 15, 1995SESE
K954377FORCEPS, GRASPING, FLEXIBLE ENDOSCOPICAnnex Medical, Inc.Oct 26, 1995SESE
K951532METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.Jul 19, 1995SESE
K951761METEL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.May 11, 1995SESE
K935737STONE EXTRACTOR, GRASPING FORCEPSBoston Scientific CorpSep 7, 1994SESE
K935721STONE EXTRACTORBoston Scientific CorpAug 22, 1994SESE
K934636ANNEX MEDICAL FLAT WIRE STONE EXTRACTORAnnex Medical, Inc.Feb 25, 1994SESE
K933260HELICAL STONE/FLATWIRE STONE BASKETSSurgitekJan 11, 1994SESE
K934675METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.Jan 7, 1994SESE
K930349STONE RETRIEVAL BASKETEndomedixJun 9, 1993SESE
K924027DISLODGER, STONE, BASKET, URETERAL, METALAnnex Medical, Inc.Oct 20, 1992SESE
K922678LOOP RETRIEVERAnnex Medical, Inc.Aug 25, 1992SESE
K922114ENDOSCOPIC RETRIEVAL BASKETIntramed Laboratories, Inc.Aug 3, 1992SESE
K921233BARD 4-WIRE URETEROSCOPIC STONEC.R. Bard, Inc.Apr 27, 1992SESE
K914505STONE BASKETSurgitek Medical Engineering Corp.Dec 9, 1991SESE
K910603LOOP RETRIEVERAnnex Medical, Inc.Mar 11, 1991SESE
K900269PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGEPorges Corp.Jul 3, 1990SESE
K896992METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.Feb 8, 1990SESE
K896169METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.Dec 18, 1989SESE
K891254UROLOGICAL STONE BASKETNorthgate Research, Inc.Mar 22, 1989SESE
K884738CANDELA STONE BASKETSCandela Laser Corp.Feb 9, 1989SESE
K871779HELICAL STONE BASKET (DISPOSABLE)Van-Tec, Inc.Jun 17, 1987SESE
K871777VAN-TEC REUSABLE HELICAL STONE BASKETVan-Tec, Inc.Jun 17, 1987SESE
K870696VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATHVan-Tec, Inc.Mar 30, 1987SESE
K870615VAN-TEC POSITIVE OPEN SEGURA BASKETVan-Tec, Inc.Mar 25, 1987SESE
K864874SEGURA DRETLER BASKETVan-Tec, Inc.Mar 10, 1987SESE
K8630814-WIRE (CARSON) STONE EXTRACTORCook Urological, Inc.Oct 24, 1986SESE
K862729PENN 3-RING HANDLEPenn Medical Devices, Inc.Oct 24, 1986SESE
K861469DUTHOY STONE BASKETLake Region Mfg., Inc.May 15, 1986SESE
K860946DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETERVan-Tec, Inc.Apr 3, 1986SESE
K860268VAN-TEC DEFLECTING GRASPING FORCEPSVan-Tec, Inc.Apr 3, 1986SESE
K860270VAN-TEC DEFLECTING ROTATING SEGURA BASKETVan-Tec, Inc.Mar 25, 1986SESE
K860269VAN-TEC DEFLECTING LOOP RETRIEVERVan-Tec, Inc.Mar 25, 1986SESE
K854652ANGIOMED URETERAL STONE DISLODGERSAngiomed U.S., Inc.Feb 10, 1986SESE
K851922URETERAL STONE DISLODGERInter-Med Corp.Aug 2, 1985SESE
K851965WILSON-COOK STONE EXTRACTORWilson-Cook Medical, Inc.Jul 29, 1985SESE
K850954URETERAL DILATOR & URETERAL STONE DISLODGERAmerican Edwards LaboratoriesApr 3, 1985SESE
K841942SEGURA BASKETVan-Tec, Inc.Jul 19, 1984SESE
K831875BALLOON DILATION HELICAL STONE EXTRACTVpiSep 12, 1983SESE
K811580GLASSMAN-DORMIA GALLSTONE EXTRACTOR SETPorges Catheter Corp.Jun 26, 1981SESE
K800608STONE DISLODGERG.D. Searle and Co.Apr 8, 1980SESE
K792344STONE AND RETRIEVAL BASKETMill-Rose LaboratoryDec 20, 1979SESE

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