Angiomed Ureteral Stone Dislodgers
FDA 510(k) K854652 · Angiomed U.S., Inc.
510(k) numberK854652
Submission
- Device name
- Angiomed Ureteral Stone Dislodgers
- Applicant
- Angiomed U.S., Inc.
Anaheim, CA, US - Received
- November 19, 1985
- Decision date
- February 10, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFL – Dislodger, Stone, Basket, Ureteral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4680
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190492 | Peralta Stone Removal CatheterFFL · Traditional | Calcula Technologies, Inc. | 07/18/2019SE |
| K172299 | Accordion Piccolo Stone Management DeviceFFL · Special | Ths International, Inc. D/B/A Accordion Medical | 09/19/2017SE |
| K102887 | Accordion Stone Management Device Model AC281205 and AC3814510FFL · Traditional | Percutaneous Systems, Inc. | 05/16/2011SE |
| K082803 | Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015FFL · Traditional | Percutaneous Systems, Inc. | 11/13/2008SE |
| K052048 | AccordionFFL · Traditional | Percutaneous Systems, Incorporated | 09/13/2005SE |
| K012581 | Reprocessed Stone Retrieval BasketsFFL · Traditional | Sterilmed, Inc. | 02/14/2002SE |
| K972091 | Ams Foreign Body ExtratorFFL · Traditional | American Medical Systems, Inc. | 08/29/1997SE |
| K970489 | Comeg Endoscopy Grasping ForcepsFFL · Traditional | Comeg Endoscopy | 03/19/1997SE |
| K962387 | Olympus FG-45/46-1 Grasping Forceps(Urology)FFL · Traditional | Olympus America, Inc. | 07/31/1996SE |
| K961248 | Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone…FFL · Traditional | C.R. Bard, Inc. | 05/28/1996SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874771 | Angiomed Introducing SetsDWB · Traditional | 01/12/1988SE |
| K874585 | Angiomed Osty-Cut Bone Biopsy NeedleDWO · Traditional | 12/02/1987SE |
| K864225 | Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentFAD · Traditional | 01/30/1987SE |
| K863386 | Vesico Suprapubic Bladder Drainage & Exchange SetsKOB · Traditional | 10/24/1986SE |
| K862805 | Angiomed Vac-U-Cut Biopsy NeedleGDM · Traditional | 09/29/1986SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | 09/23/1986SE |
| K854910 | AngioflowDQO · Traditional | 07/17/1986SE |
| K854912 | Angiomed Guied WiresDQX · Traditional | 04/16/1986SE |
| K854908 | UroflexFAD · Traditional | 03/14/1986SE |
| K855143 | Angiomed Exchange Drainage Catheter SetsKOD · Traditional | 03/11/1986SE |
Questions and answers
When was Angiomed Ureteral Stone Dislodgers cleared by the FDA?
Angiomed Ureteral Stone Dislodgers (K854652) received a 510(k) decision of Substantially Equivalent on February 10, 1986, 83 days after the submission was received.
What is the product code of K854652?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.