FGM · Class I · 21 CFR 876.4730

FDA Product Code FGM: Probe And Director, Gastro-urology

Leading manufacturers include Regulatory & Marketing Services, Inc., Blue Torch Medical Technologies and Uromed Corp..

7
Total
7
Cleared
105d
Avg days
1995
Since

FDA 510(k) Cleared Probe And Director, Gastro-urology Devices (Product Code FGM)

7 devices
1–7 of 7
Cleared Sep 21, 2004
CAVERMAP SURGICAL AID
K041732
Blue Torch Medical Technologies
Gastroenterology & Urology · 88d
Cleared Feb 11, 2000
CAVERMAP SURGICAL AID
K993436
Uromed Corp.
Gastroenterology & Urology · 122d
Cleared Feb 15, 1995
ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG
K944378
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 161d
Cleared Feb 15, 1995
ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG
K944379
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 161d
Cleared Feb 15, 1995
ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG
K944384
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 161d

About Product Code FGM - Regulatory Context