HGWClass II

Sampler, Blood, Fetal

21 CFR 884.1560 / Obstetrics/Gynecology

HGW is the FDA product code for Sampler, Blood, Fetal, a class II device type, regulated under 21 CFR 884.1560. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 1989-03-28, and no recalls.

Classification record

Product code: HGW
Device name: Sampler, Blood, Fetal
Regulation: 21 CFR 884.1560
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 4
Ingested recalls: 0

Clearances, product code HGW

By decision year

4 clearances under product code HGW with a decision year between 1981 and 1989, 1989 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HGW by decision year
Year	Clearances
1981	1
1983	1
1989	2

Applicants with the most clearances

Product code HGW

Applicants holding the most 510(k) clearances under product code HGW
Applicant	Clearances
Transidyne General Corp.	3
A & A Medical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code HGW

Recent recalls

Product code HGW

FDA records show no recalls under product code HGW.

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)