# K200886: StimSite

- Pathway: 510(k) (Traditional)
- Applicant: Allotrope Medical, Inc.
- Decided: Nov 10, 2020 after 222 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K844216 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993436: Cavermap Surgical Aid, Uromed Corp. (2000) Summary page 4.
- K092292: Checkpoint, Ndi Medical, LLC (2009) Summary page 4.

## Indications for use
StimSite is a non-sterile device intended to provide electrical stimulation to ureter smooth muscle tissue to help locate and identify ureters by testing ureter smooth muscle excitability.

Source page: https://510kreport.com/device/K200886
Methodology: https://510kreport.com/methodology