Ureteral Stone Dislodger
FDA 510(k) K851922 · Inter-Med Corp.
510(k) numberK851922
Submission
- Device name
- Ureteral Stone Dislodger
- Applicant
- Inter-Med Corp.
Danielson, CT, US - Received
- May 2, 1985
- Decision date
- August 2, 1985
- 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
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| 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 |
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Questions and answers
When was Ureteral Stone Dislodger cleared by the FDA?
Ureteral Stone Dislodger (K851922) received a 510(k) decision of Substantially Equivalent on August 2, 1985, 92 days after the submission was received.
What is the product code of K851922?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.