Dislodger, Stone, Flexible
FDA product code FGO · Class II (moderate risk) · 21 CFR 876.4680 · Gastroenterology, Urology
19510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001563 | Scipro(Tm) Flexible Stone Dislodger and Retrieval SetFGO · Traditional | Scion Cardiovascular, Inc. | 11/22/2000SE |
| K970121 | Stone Dislodger, BasketFGO · Traditional | Boston Scientific Corp | 04/02/1997SE |
| K963750 | Retrieval SnareFGO · Traditional | Boston Scientific Corp | 11/22/1996SE |
| K962676 | Disposable Endoscopic Retrieval DeviceFGO · Traditional | United States Endoscopy Group, Inc. | 10/04/1996SE |
| K951309 | Stone Dislodger, BasketFGO · Traditional | Boston Scientific Corp | 05/17/1995SE |
| K933261 | Grasping ForcepsFGO · Traditional | Surgitek | 01/11/1994SE |
| K934598 | Grasping Forceps or Retrieval ForcepsFGO · Traditional | Annex Medical, Inc. | 01/07/1994SE |
| K921295 | Intravenous Catheters ModificationsFGO · Traditional | Critikon Company, LLC | 05/17/1993SE |
| K922542 | Grasping ForcepsFGO · Traditional | Surgitek | 08/19/1992SE |
| K914112 | Metal Ureteral Basket Stone Dislodger, Flat WireFGO · Traditional | Annex Medical, Inc. | 02/28/1992SE |
| K914111 | Metal Ureteral Basket Stone Dislodger, HelicalFGO · Traditional | Annex Medical, Inc. | 02/28/1992SE |
| K914110 | Grasping ForcepsFGO · Traditional | Annex Medical, Inc. | 02/28/1992SE |
| K896322 | CN Gaurd, Sterile Latex Surgical GlovesFGO · Traditional | C.N. Technocrats | 07/12/1990SE |
| K895080 | Surgical GlovesFGO · Traditional | Jet Far Industries, Inc. | 01/24/1990SE |
| K893522 | Surgeon's GlovesFGO · Traditional | Thai Fuji Latex Co., Ltd. | 01/22/1990SE |
| K885168 | Rubenstein Ureteral Stone Fragment BrushFGO · Traditional | Boston Scientific Corp | 09/08/1989SE |
| K891253 | Urological Grasping ForcepsFGO · Traditional | Northgate Research, Inc. | 03/22/1989SE |
| K891252 | Urological Loop RetrieversFGO · Traditional | Northgate Research, Inc. | 03/22/1989SE |
| K771302 | Pfister-Schwartz Stone RetrieverFGO · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 08/02/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0006-2013 Class II | Endoscopic retrieval device. The disposable Raptor grasping device in intended to…When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the… | US Endoscopy Group Inc | 11/14/2011Terminated |