# K182664: FiXcision

- Pathway: 510(k) (Traditional)
- Applicant: Agency For Medical Innovations GmbH
- Decided: Dec 7, 2018 after 73 days
- Product code: KOA (Surgical Instruments, G-U, Manual (And Accessories))
- Device class: 1
- Regulation: 21 CFR 876.4730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K760715 (1976). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760715: Flexible Cutting Scissors, V. Mueller O.V. Baxter Healthcare Corp. (1976) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K182664
Methodology: https://510kreport.com/methodology