Product code FGO
- Device name
- Dislodger, Stone, Flexible
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4680
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001563 | SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET | Scion Cardiovascular, Inc. | 2000-11-22 |
| K970121 | STONE DISLODGER, BASKET | Boston Scientific Corp | 1997-04-02 |
| K963750 | RETRIEVAL SNARE | Boston Scientific Corp | 1996-11-22 |
| K962676 | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE | United States Endoscopy Group, Inc. | 1996-10-04 |
| K951309 | STONE DISLODGER, BASKET | Boston Scientific Corp | 1995-05-17 |
| K933261 | GRASPING FORCEPS | Surgitek | 1994-01-11 |
| K934598 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Annex Medical, Inc. | 1994-01-07 |
| K921295 | INTRAVENOUS CATHETERS MODIFICATIONS | Critikon Company, LLC | 1993-05-17 |
| K922542 | GRASPING FORCEPS | Surgitek | 1992-08-19 |
| K914111 | METAL URETERAL BASKET STONE DISLODGER, HELICAL | Annex Medical, Inc. | 1992-02-28 |
| K914112 | METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE | Annex Medical, Inc. | 1992-02-28 |
| K914110 | GRASPING FORCEPS | Annex Medical, Inc. | 1992-02-28 |
| K896322 | CN GAURD, STERILE LATEX SURGICAL GLOVES | C.N. Technocrats | 1990-07-12 |
| K895080 | SURGICAL GLOVES | Jet Far Industries, Inc. | 1990-01-24 |
| K893522 | SURGEON'S GLOVES | Thai Fuji Latex Co., Ltd. | 1990-01-22 |
| K885168 | RUBENSTEIN URETERAL STONE FRAGMENT BRUSH | Boston Scientific Corp | 1989-09-08 |
| K891253 | UROLOGICAL GRASPING FORCEPS | Northgate Research, Inc. | 1989-03-22 |
| K891252 | UROLOGICAL LOOP RETRIEVERS | Northgate Research, Inc. | 1989-03-22 |
| K771302 | PFISTER-SCHWARTZ STONE RETRIEVER | V. Mueller O.V. Baxter Healthcare Corp. | 1977-08-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00821925044326 | SOLTIVE | Gyrus ACMI, LLC | 2020-03-23 |
| 00724995182663 | Falcon | US Endoscopy | 2020-03-19 |
| 00724995182786 | Talon | US Endoscopy | 2020-03-19 |
| 10724995182660 | Falcon | US Endoscopy | 2020-03-19 |
| 10724995182783 | Talon | US Endoscopy | 2020-03-19 |
| 00810116022373 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022366 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022359 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022342 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022335 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022328 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022311 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022304 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022908 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00810116022915 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2020-02-18 |
| 00821925041349 | OLYMPUS | Gyrus ACMI, LLC | 2020-01-28 |
| 00810116020591 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2018-12-04 |
| 00810116020584 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2018-12-04 |
| 00810116020577 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | 2018-12-04 |
| 00821925003187 | USA Elite | Gyrus ACMI, LLC | 2016-10-14 |
| 00821925001268 | USA Elite | Gyrus ACMI, LLC | 2016-10-13 |
| 08714729430223 | Stone Cone | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729430209 | Stone Cone | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 07613327064131 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327064162 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327064186 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327064193 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327064209 | NA | STRYKER CORPORATION | 2016-09-23 |
| 00816765011300 | Talon | US Endoscopy | 2016-09-17 |
| 00816765011171 | Falcon | US Endoscopy | 2016-09-17 |