The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area.
The FDA approval was given on the basis of the positive results from a clinical trial involving 206 patients.
In the primary study, most patients received two treatments, consisting of four injections each, for a total of eight injections.
Following six months, more than half of the patients injected with Solesta demonstrated a 50% reduction in the number of fecal incontinence episodes.
However, one-third of patients who received no Solesta in the study also experienced a similar reduction.
Overall, a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit.
FDA Center for Devices and Radiological Health director Christy Foreman said this approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies.