FTOClass III

Prosthesis, Testicle

21 CFR 876.3750 / Gastroenterology, Urology

FTO is the FDA product code for Prosthesis, Testicle, a class III device type, regulated under 21 CFR 876.3750. FDA's definition for this code reads: "Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: FTO
Device name: Prosthesis, Testicle
FDA definition: Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
Regulation: 21 CFR 876.3750
Device class: Class III
Review panel: Gastroenterology, Urology
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FTO.

Recent clearances

Product code FTO

FDA records hold no clearances under product code FTO.

Recent recalls

Product code FTO

FDA records show no recalls under product code FTO.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)