510(k) · Cleared
ClearedCoaxial Accordion Stone Management Device, Model: COAC12005 - COA20015
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Percutaneous Systems, Inc. · FFL Dislodger, Stone, Basket, Ureteral, Metal
Cleared on Nov 13, 2008 after a 50-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 13, 2008
- Review
- 50 days
- Class
- Class II
- Product code
- FFL
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK082803 Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015Percutaneous Systems, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK172299 Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical · 2017
Most influential descendants
Showing 1 of 1 · See all- K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion Medical · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082803 | Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015 | Percutaneous Systems, Inc. | 2008 | — |
| +1 | K172299 | Accordion Piccolo Stone Management Device | Ths International, Inc. D/B/A Accordion Medical | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Accordion Urological Occluding Guidewire, Percutaneous Systems, Inc. Named without a submission number | |
| * | — | Open-end Ureteral Catheter, Cook Urologic Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172299 | Accordion Piccolo Stone Management Device | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K172299 (Ths International, Inc. D/B/A Accordion Medical, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FFL devicesFFL Dislodger, Stone, Basket, Ureteral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FFL
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FFL
Too few FFL 510(k)s in any year since 2007 to give a median.
Recalls per year · FFL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFL
496in 2025
MAUDE reports naming product code FFL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 68 |
| 2008 | 1 | — | 1 | 152 |
| 2009 | 0 | — | 0 | 194 |
| 2010 | 0 | — | 0 | 192 |
| 2011 | 1 | — | 0 | 129 |
| 2012 | 0 | — | 0 | 95 |
| 2013 | 0 | — | 0 | 98 |
| 2014 | 0 | — | 1 | 71 |
| 2015 | 0 | — | 0 | 79 |
| 2016 | 0 | — | 0 | 88 |
| 2017 | 1 | — | 0 | 517 |
| 2018 | 0 | — | 0 | 428 |
| 2019 | 1 | — | 0 | 351 |
| 2020 | 0 | — | 0 | 375 |
| 2021 | 0 | — | 0 | 358 |
| 2022 | 0 | — | 1 | 426 |
| 2023 | 0 | — | 0 | 593 |
| 2024 | 0 | — | 0 | 606 |
| 2025 | 0 | — | 0 | 496 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Coaxial Accordion Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082803: Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082803
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026