Urological Loop Retrievers
FDA 510(k) K891252 · Northgate Research, Inc.
510(k) numberK891252
Submission
- Device name
- Urological Loop Retrievers
- Applicant
- Northgate Research, Inc.
Arlington Heights, IL, US - Received
- March 8, 1989
- Decision date
- March 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FGO – Dislodger, Stone, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4680
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FGO
| 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 |
More from Annex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903337 | 1.9 French Lithotripter ElectrodeFFK · Traditional | 11/16/1990SE |
| K894704 | 2.5 French Lithotriptor ElectrodeFFK · Traditional | 10/18/1989SE |
| K891254 | Urological Stone BasketFFL · Traditional | 03/22/1989SE |
| K891253 | Urological Grasping ForcepsFGO · Traditional | 03/22/1989SE |
| K864904 | 3F ElectrodeFFK · Traditional | 02/10/1987SE |
| K852874 | 5F Electrode(Lithotriptor)FFK · Traditional | 08/21/1985SE |
| K802322 | Model SD-1 DisintegratorFFK · Traditional | 11/10/1980SE |
Questions and answers
When was Urological Loop Retrievers cleared by the FDA?
Urological Loop Retrievers (K891252) received a 510(k) decision of Substantially Equivalent on March 22, 1989, 14 days after the submission was received.
What is the product code of K891252?
The FDA product code is FGO – Dislodger, Stone, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4680.