Accordion Stone Management Device Model AC281205 and AC3814510
FDA 510(k) K102887 · Percutaneous Systems, Inc.
510(k) numberK102887
Submission
- Device name
- Accordion Stone Management Device Model AC281205 and AC3814510
- Applicant
- Percutaneous Systems, Inc.
Palo Alto, CA, US - Received
- September 30, 2010
- Decision date
- May 16, 2011
- 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
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 |
| 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 |
More from Olympus America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090485 | Coaxial Accordion Ercp Device, Models C0AC19001, COAC20005, COAC22003LQR · Traditional | 07/22/2009SE |
| K082803 | Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015FFL · Traditional | 11/13/2008SE |
| K061766 | Expressway Intermittent CatheterEZD · Traditional | 03/09/2007SE |
| K052298 | Cystoglide Introducer SheathKNY · Traditional | 12/12/2006SE |
| K052134 | Cystoglide Dilating Introducer SheathKNY · Traditional | 09/22/2005SE |
| K052048 | AccordionFFL · Traditional | 09/13/2005SE |
| K042531 | Updated Slip Urology Introducer SheathKNY · Special | 02/01/2005SE |
| K042877 | Microverter Ureteral Access SheathKNY · Traditional | 11/16/2004SE |
| K040520 | Slip Urology Introducer SheathKNY · Traditional | 05/20/2004SE |
| K040519 | Slip Urology CatheterEZD · Traditional | 05/20/2004SE |
Questions and answers
When was Accordion Stone Management Device Model AC281205 and AC3814510 cleared by the FDA?
Accordion Stone Management Device Model AC281205 and AC3814510 (K102887) received a 510(k) decision of Substantially Equivalent on May 16, 2011, 228 days after the submission was received.
What is the product code of K102887?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.