FAAClass III

Replacer, Urethral

Unknown

FAA is the FDA product code for Replacer, Urethral, a class III device type. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1983-11-29, and no recalls.

Classification record

Product code: FAA
Device name: Replacer, Urethral
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code FAA

By decision year

1 clearance under product code FAA with a decision year between 1983 and 1983, 1983 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code FAA by decision year
Year	Clearances
1983	1

Applicants with the most clearances

Product code FAA

Applicants holding the most 510(k) clearances under product code FAA
Applicant	Clearances
American Edwards Laboratories	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code FAA

K833690Class IIICoaxial Balloon Urethral DilatorAmerican Edwards Laboratories / cleared 1983-11-29

Recent recalls

Product code FAA

FDA records show no recalls under product code FAA.

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)