Product Code: FGO FDA class 2 21 CFR 876.4680

Dislodger, Stone, Flexible

Gastroenterology, Urology

The Flexible Stone Dislodger is a flexible wire-based device used to dislodge and assist in the retrieval of calculi from the urinary tract, particularly from the ureter or renal pelvis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FGO, regulated under 21 CFR 876.4680, within the Gastroenterology, Urology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FGO
Device Class: FDA class 2
Regulation Number: 876.4680
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K001563	SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET	Nov 22, 2000	Substantially Equivalent	Scion Cardiovascular, Inc.
K970121	STONE DISLODGER, BASKET	Apr 02, 1997	Substantially Equivalent	Boston Scientific Corp
K963750	RETRIEVAL SNARE	Nov 22, 1996	Substantially Equivalent	Boston Scientific Corp
K962676	DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE	Oct 04, 1996	Substantially Equivalent	United States Endoscopy Group, Inc.
K951309	STONE DISLODGER, BASKET	May 17, 1995	Substantially Equivalent	Boston Scientific Corp
K933261	GRASPING FORCEPS	Jan 11, 1994	Substantially Equivalent	Surgitek
K934598	GRASPING FORCEPS OR RETRIEVAL FORCEPS	Jan 07, 1994	Substantially Equivalent	Annex Medical, Inc.
K921295	INTRAVENOUS CATHETERS MODIFICATIONS	May 17, 1993	Substantially Equivalent	Critikon Company, LLC
K922542	GRASPING FORCEPS	Aug 19, 1992	Substantially Equivalent	Surgitek
K914112	METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE	Feb 28, 1992	Substantially Equivalent	Annex Medical, Inc.
K914111	METAL URETERAL BASKET STONE DISLODGER, HELICAL	Feb 28, 1992	Substantially Equivalent	Annex Medical, Inc.
K914110	GRASPING FORCEPS	Feb 28, 1992	Substantially Equivalent	Annex Medical, Inc.
K896322	CN GAURD, STERILE LATEX SURGICAL GLOVES	Jul 12, 1990	Substantially Equivalent	C.N. Technocrats
K895080	SURGICAL GLOVES	Jan 24, 1990	Substantially Equivalent	Jet Far Industries, Inc.
K893522	SURGEON'S GLOVES	Jan 22, 1990	Substantially Equivalent	Thai Fuji Latex Co., Ltd.
K885168	RUBENSTEIN URETERAL STONE FRAGMENT BRUSH	Sep 08, 1989	Substantially Equivalent	Boston Scientific Corp
K891253	UROLOGICAL GRASPING FORCEPS	Mar 22, 1989	Substantially Equivalent	Northgate Research, Inc.
K891252	UROLOGICAL LOOP RETRIEVERS	Mar 22, 1989	Substantially Equivalent	Northgate Research, Inc.
K771302	PFISTER-SCHWARTZ STONE RETRIEVER	Aug 02, 1977	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.