FGMClass I

Probe And Director, Gastro-Urology

21 CFR 876.4730 / Gastroenterology, Urology

FGM is the FDA product code for Probe And Director, Gastro-Urology, a class I device type, regulated under 21 CFR 876.4730. As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 2004-09-21, and one recall.

Classification record

Product code: FGM
Device name: Probe And Director, Gastro-Urology
Regulation: 21 CFR 876.4730
Device class: Class I
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 7
Ingested recalls: 1

Clearances, product code FGM

By decision year

7 clearances under product code FGM with a decision year between 1995 and 2004, 1995 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code FGM by decision year
Year	Clearances
1995	3
2000	1
2001	1
2003	1
2004	1

Applicants with the most clearances

Product code FGM

Applicants holding the most 510(k) clearances under product code FGM
Applicant	Clearances
Regulatory & Marketing Services, Inc.	3
Blue Torch Medical Technologies	2
Uromed Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 101 companies shown, in name order