Atlas FDA

FGO

19 FDA 510(k) clearances · Product code

163 daysmedian time to decision
269 days90th percentile
19clearances measured

FDA profile

Official device name
Dislodger, Stone, Flexible
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4680
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2018: 14 · 2019: 25 · 2020: 19 · 2021: 14 · 2022: 18 · 2024: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (K001563)Scion Cardiovascular, Inc.2000-11-22
STONE DISLODGER, BASKET (K970121)Boston Scientific Corp1997-04-02
RETRIEVAL SNARE (K963750)Boston Scientific Corp1996-11-22
DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (K962676)United States Endoscopy Group, Inc.1996-10-04
STONE DISLODGER, BASKET (K951309)Boston Scientific Corp1995-05-17
GRASPING FORCEPS (K933261)Surgitek1994-01-11
GRASPING FORCEPS OR RETRIEVAL FORCEPS (K934598)Annex Medical, Inc.1994-01-07
INTRAVENOUS CATHETERS MODIFICATIONS (K921295)Critikon Company, LLC1993-05-17
GRASPING FORCEPS (K922542)Surgitek1992-08-19
METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE (K914112)Annex Medical, Inc.1992-02-28
METAL URETERAL BASKET STONE DISLODGER, HELICAL (K914111)Annex Medical, Inc.1992-02-28
GRASPING FORCEPS (K914110)Annex Medical, Inc.1992-02-28
CN GAURD, STERILE LATEX SURGICAL GLOVES (K896322)C.N. Technocrats1990-07-12
SURGICAL GLOVES (K895080)Jet Far Industries, Inc.1990-01-24
SURGEON'S GLOVES (K893522)Thai Fuji Latex Co., Ltd.1990-01-22
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH (K885168)Boston Scientific Corp1989-09-08
UROLOGICAL LOOP RETRIEVERS (K891252)Northgate Research, Inc.1989-03-22
UROLOGICAL GRASPING FORCEPS (K891253)Northgate Research, Inc.1989-03-22
PFISTER-SCHWARTZ STONE RETRIEVER (K771302)V. Mueller O.V. Baxter Healthcare Corp.1977-08-02

Track FGO automatically

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