Accordion Piccolo Stone Management Device
FDA 510(k) K172299 · Ths International, Inc. D/B/A Accordion Medical
510(k) numberK172299
Submission
- Device name
- Accordion Piccolo Stone Management Device
- Applicant
- Ths International, Inc. D/B/A Accordion Medical
Indianapolis, IN, US - Received
- July 31, 2017
- Decision date
- September 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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 |
| 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 |
| K955049 | Olympus FG-45/46-1 Grasping ForcepsFFL · Traditional | Olympus America, Inc. | 12/15/1995SE |
Questions and answers
When was Accordion Piccolo Stone Management Device cleared by the FDA?
Accordion Piccolo Stone Management Device (K172299) received a 510(k) decision of Substantially Equivalent on September 19, 2017, 50 days after the submission was received.
What is the product code of K172299?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.