HDTClass III

Device, Intrauterine, Contraceptive And Introducer

21 CFR 884.5360 / Obstetrics/Gynecology

HDT is the FDA product code for Device, Intrauterine, Contraceptive And Introducer, a class III device type, regulated under 21 CFR 884.5360. FDA's definition for this code reads: "Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: HDT
Device name: Device, Intrauterine, Contraceptive And Introducer
FDA definition: Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86
Regulation: 21 CFR 884.5360
Device class: Class III
Review panel: Obstetrics/Gynecology
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 HDT.

Recent clearances

Product code HDT

FDA records hold no clearances under product code HDT.

Recent recalls

Product code HDT

FDA records show no recalls under product code HDT.

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)