Atlas FDA

FFL

52 FDA 510(k) clearances · Product code

61 daysmedian time to decision
166 days90th percentile
52clearances measured

FDA profile

Official device name
Dislodger, Stone, Basket, Ureteral, Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4680
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 358 · 2022: 426 · 2023: 593 · 2024: 607 · 2025: 511 · 2026: 225
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Peralta Stone Removal Catheter (K190492)Calcula Technologies, Inc.2019-07-18
Accordion Piccolo Stone Management Device (K172299)Ths International, Inc. D/B/A Accordion Medical2017-09-19
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (K102887)Percutaneous Systems, Inc.2011-05-16
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (K082803)Percutaneous Systems, Inc.2008-11-13
ACCORDION (K052048)Percutaneous Systems, Incorporated2005-09-13
REPROCESSED STONE RETRIEVAL BASKETS (K012581)Sterilmed, Inc.2002-02-14
AMS FOREIGN BODY EXTRATOR (K972091)American Medical Systems, Inc.1997-08-29
COMEG ENDOSCOPY GRASPING FORCEPS (K970489)Comeg Endoscopy1997-03-19
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) (K962387)Olympus America, Inc.1996-07-31
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS (K961248)C.R. Bard, Inc.1996-05-28
OLYMPUS FG-45/46-1 GRASPING FORCEPS (K955049)Olympus America, Inc.1995-12-15
FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC (K954377)Annex Medical, Inc.1995-10-26
METAL URETERAL BASKET STONE DISLODGER (K951532)Annex Medical, Inc.1995-07-19
METEL URETERAL BASKET STONE DISLODGER (K951761)Annex Medical, Inc.1995-05-11
STONE EXTRACTOR, GRASPING FORCEPS (K935737)Boston Scientific Corp1994-09-07
STONE EXTRACTOR (K935721)Boston Scientific Corp1994-08-22
ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR (K934636)Annex Medical, Inc.1994-02-25
HELICAL STONE/FLATWIRE STONE BASKETS (K933260)Surgitek1994-01-11
METAL URETERAL BASKET STONE DISLODGER (K934675)Annex Medical, Inc.1994-01-07
STONE RETRIEVAL BASKET (K930349)Endomedix1993-06-09
DISLODGER, STONE, BASKET, URETERAL, METAL (K924027)Annex Medical, Inc.1992-10-20
LOOP RETRIEVER (K922678)Annex Medical, Inc.1992-08-25
ENDOSCOPIC RETRIEVAL BASKET (K922114)Intramed Laboratories, Inc.1992-08-03
BARD 4-WIRE URETEROSCOPIC STONE (K921233)C.R. Bard, Inc.1992-04-27
STONE BASKET (K914505)Surgitek Medical Engineering Corp.1991-12-09
LOOP RETRIEVER (K910603)Annex Medical, Inc.1991-03-11
PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE (K900269)Porges Corp.1990-07-03
METAL URETERAL BASKET STONE DISLODGER (K896992)Annex Medical, Inc.1990-02-08
METAL URETERAL BASKET STONE DISLODGER (K896169)Annex Medical, Inc.1989-12-18
UROLOGICAL STONE BASKET (K891254)Northgate Research, Inc.1989-03-22
CANDELA STONE BASKETS (K884738)Candela Laser Corp.1989-02-09
VAN-TEC REUSABLE HELICAL STONE BASKET (K871777)Van-Tec, Inc.1987-06-17
HELICAL STONE BASKET (DISPOSABLE) (K871779)Van-Tec, Inc.1987-06-17
VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH (K870696)Van-Tec, Inc.1987-03-30
VAN-TEC POSITIVE OPEN SEGURA BASKET (K870615)Van-Tec, Inc.1987-03-25
SEGURA DRETLER BASKET (K864874)Van-Tec, Inc.1987-03-10
PENN 3-RING HANDLE (K862729)Penn Medical Devices, Inc.1986-10-24
4-WIRE (CARSON) STONE EXTRACTOR (K863081)Cook Urological, Inc.1986-10-24
DUTHOY STONE BASKET (K861469)Lake Region Mfg., Inc.1986-05-15
VAN-TEC DEFLECTING GRASPING FORCEPS (K860268)Van-Tec, Inc.1986-04-03
DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER (K860946)Van-Tec, Inc.1986-04-03
VAN-TEC DEFLECTING LOOP RETRIEVER (K860269)Van-Tec, Inc.1986-03-25
VAN-TEC DEFLECTING ROTATING SEGURA BASKET (K860270)Van-Tec, Inc.1986-03-25
ANGIOMED URETERAL STONE DISLODGERS (K854652)Angiomed U.S., Inc.1986-02-10
URETERAL STONE DISLODGER (K851922)Inter-Med Corp.1985-08-02
WILSON-COOK STONE EXTRACTOR (K851965)Wilson-Cook Medical, Inc.1985-07-29
URETERAL DILATOR & URETERAL STONE DISLODGER (K850954)American Edwards Laboratories1985-04-03
SEGURA BASKET (K841942)Van-Tec, Inc.1984-07-19
BALLOON DILATION HELICAL STONE EXTRACT (K831875)Vpi1983-09-12
GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET (K811580)Porges Catheter Corp.1981-06-26
STONE DISLODGER (K800608)G.D. Searle and Co.1980-04-08
STONE AND RETRIEVAL BASKET (K792344)Mill-Rose Laboratory1979-12-20

Track FFL automatically

Every clearance here is in the API, with alerts when new ones post.