Stone Retrieval Basket
FDA 510(k) K930349 · Endomedix
510(k) numberK930349
Submission
- Device name
- Stone Retrieval Basket
- Applicant
- Endomedix
Irvine, CA, US - Received
- January 25, 1993
- Decision date
- June 9, 1993
- 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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| K102887 | Accordion Stone Management Device Model AC281205 and AC3814510FFL · Traditional | Percutaneous Systems, Inc. | 05/16/2011SE |
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| 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 |
|---|---|---|
| K934170 | Endomedix Y-AdapterOCX · Traditional | 01/11/1994SE |
| K934623 | Endoscopic Video System and Endoscopic Video CameraFET · Traditional | 12/02/1993SE |
| K930499 | Grasping Forceps Flexible Stone DislodgerOCZ · Traditional | 08/16/1993SE |
| K926004 | Endoscope and AccossoriesFGB · Traditional | 02/10/1993SE |
| K922837 | S1500 Xenon Light SourceHBI · Traditional | 11/03/1992SE |
| K922082 | Laparoscopic IntroducerGCJ · Traditional | 08/03/1992SE |
Questions and answers
When was Stone Retrieval Basket cleared by the FDA?
Stone Retrieval Basket (K930349) received a 510(k) decision of Substantially Equivalent on June 9, 1993, 135 days after the submission was received.
What is the product code of K930349?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.