510(k) · Cleared
ClearedFiXcision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agency For Medical Innovations GmbH · KOA Surgical Instruments, G-U, Manual (And Accessories)
Cleared on Dec 7, 2018 as substantially equivalent to K760715 (V. Mueller O.V. Baxter Healthcare Corp., 1976) after a 73-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Dec 7, 2018
- Review
- 73 days
- Class
- Class I
- Product code
- KOA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K760715 (1976). No later device cites it as a predicate yet.
- Root · 1 generation backK760715 Flexible Cutting ScissorsV. Mueller O.V. Baxter Healthcare Corp. · 1976
- This deviceK182664 FiXcisionAgency For Medical Innovations GmbH · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760715 | Flexible Cutting Scissors | V. Mueller O.V. Baxter Healthcare Corp. | 1976 | — |
| 0 (this device) | K182664 | FiXcision | Agency For Medical Innovations GmbH | 2018 | — |
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 KOA? 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? (1)
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 |
|---|---|---|---|
| * | K760715 | Flexible Cutting ScissorsSummary page 5…ION The FiXcision device is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K760715 Flexible Cutting Scissors / V. Mueller O.V.… | 1976 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All KOA devicesKOA Surgical Instruments, G-U, Manual (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KOA
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KOA
Too few KOA 510(k)s in any year since 2007 to give a median.
Recalls per year · KOA
No recall names KOA since 2007.
Adverse event reports per year · KOA
3in 2025
MAUDE reports naming product code KOA, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182664: FiXcision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182664
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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