Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone Baskets/Grasping Forceps
FDA 510(k) K961248 · C.R. Bard, Inc.
510(k) numberK961248
Submission
- Device name
- Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone Baskets/Grasping Forceps
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- April 1, 1996
- Decision date
- May 28, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K052048 | AccordionFFL · Traditional | Percutaneous Systems, Incorporated | 09/13/2005SE |
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| 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 |
| K955049 | Olympus FG-45/46-1 Grasping ForcepsFFL · Traditional | Olympus America, Inc. | 12/15/1995SE |
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Questions and answers
When was Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone Baskets/Grasping Forceps cleared by the FDA?
Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone Baskets/Grasping Forceps (K961248) received a 510(k) decision of Substantially Equivalent on May 28, 1996, 57 days after the submission was received.
What is the product code of K961248?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.