FGO · Dislodger, Stone, Flexible
Gastroenterology, Urology · 21 CFR 876.4680 · Class 2
Overview
| Product Code | FGO |
|---|---|
| Device Name | Dislodger, Stone, Flexible |
| Regulation | 21 CFR 876.4680 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
Cleared Devices (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001563 | SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET | Scion Cardiovascular, Inc. | Nov 22, 2000 | SESE |
| K970121 | STONE DISLODGER, BASKET | Boston Scientific Corp | Apr 2, 1997 | SESE |
| K963750 | RETRIEVAL SNARE | Boston Scientific Corp | Nov 22, 1996 | SESE |
| K962676 | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE | United States Endoscopy Group, Inc. | Oct 4, 1996 | SESE |
| K951309 | STONE DISLODGER, BASKET | Boston Scientific Corp | May 17, 1995 | SESE |
| K933261 | GRASPING FORCEPS | Surgitek | Jan 11, 1994 | SESE |
| K934598 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Annex Medical, Inc. | Jan 7, 1994 | SESE |
| K921295 | INTRAVENOUS CATHETERS MODIFICATIONS | Critikon Company, LLC | May 17, 1993 | SESE |
| K922542 | GRASPING FORCEPS | Surgitek | Aug 19, 1992 | SESE |
| K914112 | METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE | Annex Medical, Inc. | Feb 28, 1992 | SESE |
| K914111 | METAL URETERAL BASKET STONE DISLODGER, HELICAL | Annex Medical, Inc. | Feb 28, 1992 | SESE |
| K914110 | GRASPING FORCEPS | Annex Medical, Inc. | Feb 28, 1992 | SESE |
| K896322 | CN GAURD, STERILE LATEX SURGICAL GLOVES | C.N. Technocrats | Jul 12, 1990 | SESE |
| K895080 | SURGICAL GLOVES | Jet Far Industries, Inc. | Jan 24, 1990 | SESE |
| K893522 | SURGEON'S GLOVES | Thai Fuji Latex Co., Ltd. | Jan 22, 1990 | SESE |
| K885168 | RUBENSTEIN URETERAL STONE FRAGMENT BRUSH | Boston Scientific Corp | Sep 8, 1989 | SESE |
| K891253 | UROLOGICAL GRASPING FORCEPS | Northgate Research, Inc. | Mar 22, 1989 | SESE |
| K891252 | UROLOGICAL LOOP RETRIEVERS | Northgate Research, Inc. | Mar 22, 1989 | SESE |
| K771302 | PFISTER-SCHWARTZ STONE RETRIEVER | V. Mueller O.V. Baxter Healthcare Corp. | Aug 2, 1977 | SESE |
Top Applicants
- Boston Scientific Corp — 4 clearances
- Annex Medical, Inc. — 4 clearances
- Surgitek — 2 clearances
- Northgate Research, Inc. — 2 clearances
- V. Mueller O.V. Baxter Healthcare Corp. — 1 clearance
