FAFClass III

Prosthesis, Testicular

21 CFR 876.3750 / Gastroenterology, Urology

FAF is the FDA product code for Prosthesis, Testicular, 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 one recall.

Classification record

Product code: FAF
Device name: Prosthesis, Testicular
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: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code FAF

FDA records hold no clearances under product code FAF.

Recent recalls

Product code FAF

Z-0820-2011On April 22, 2010, a decision was made by Coloplast to conduct a field correction based on a report that the Saline Filled...Coloplast Manufacturing US, LLC / initiated 2010-04-30 / 1018

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)