Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4680](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4680) → FGO — Dislodger, Stone, Flexible # FGO · Dislodger, Stone, Flexible _Gastroenterology, Urology · 21 CFR 876.4680 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO ## Overview - **Product Code:** FGO - **Device Name:** Dislodger, Stone, Flexible - **Regulation:** [21 CFR 876.4680](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4680) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## 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. ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K001563](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K001563.md) | SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET | Scion Cardiovascular, Inc. | Nov 22, 2000 | SESE | | [K970121](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K970121.md) | STONE DISLODGER, BASKET | Boston Scientific Corp | Apr 2, 1997 | SESE | | [K963750](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K963750.md) | RETRIEVAL SNARE | Boston Scientific Corp | Nov 22, 1996 | SESE | | [K962676](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K962676.md) | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE | United States Endoscopy Group, Inc. | Oct 4, 1996 | SESE | | [K951309](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K951309.md) | STONE DISLODGER, BASKET | Boston Scientific Corp | May 17, 1995 | SESE | | [K933261](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K933261.md) | GRASPING FORCEPS | Surgitek | Jan 11, 1994 | SESE | | [K934598](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K934598.md) | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Annex Medical, Inc. | Jan 7, 1994 | SESE | | [K921295](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K921295.md) | INTRAVENOUS CATHETERS MODIFICATIONS | Critikon Company, LLC | May 17, 1993 | SESE | | [K922542](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K922542.md) | GRASPING FORCEPS | Surgitek | Aug 19, 1992 | SESE | | [K914112](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K914112.md) | METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE | Annex Medical, Inc. | Feb 28, 1992 | SESE | | [K914111](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K914111.md) | METAL URETERAL BASKET STONE DISLODGER, HELICAL | Annex Medical, Inc. | Feb 28, 1992 | SESE | | [K914110](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K914110.md) | GRASPING FORCEPS | Annex Medical, Inc. | Feb 28, 1992 | SESE | | [K896322](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K896322.md) | CN GAURD, STERILE LATEX SURGICAL GLOVES | C.N. Technocrats | Jul 12, 1990 | SESE | | [K895080](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K895080.md) | SURGICAL GLOVES | Jet Far Industries, Inc. | Jan 24, 1990 | SESE | | [K893522](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K893522.md) | SURGEON'S GLOVES | Thai Fuji Latex Co., Ltd. | Jan 22, 1990 | SESE | | [K885168](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K885168.md) | RUBENSTEIN URETERAL STONE FRAGMENT BRUSH | Boston Scientific Corp | Sep 8, 1989 | SESE | | [K891253](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K891253.md) | UROLOGICAL GRASPING FORCEPS | Northgate Research, Inc. | Mar 22, 1989 | SESE | | [K891252](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K891252.md) | UROLOGICAL LOOP RETRIEVERS | Northgate Research, Inc. | Mar 22, 1989 | SESE | | [K771302](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO/K771302.md) | PFISTER-SCHWARTZ STONE RETRIEVER | V. Mueller O.V. Baxter Healthcare Corp. | Aug 2, 1977 | SESE | ## Top Applicants - Annex Medical, Inc. — 4 clearances - Boston Scientific Corp — 4 clearances - Northgate Research, Inc. — 2 clearances - Surgitek — 2 clearances - C.N. Technocrats — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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