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FGM — Probe And Director, Gastro-Urology Class I

FDA Device Classification

Classification Details

Product Code
FGM
Device Class
Class I
Regulation Number
876.4730
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K041732blue torch medical technologiesCAVERMAP SURGICAL AIDSeptember 21, 2004
K031527blue torch medical technologiesMODIFICATION TO CAVERMAP SURGICAL AIDJune 5, 2003
K010098uromedMODIFICATION TO CAVERMAP SURGICAL AIDFebruary 1, 2001
K993436uromedCAVERMAP SURGICAL AIDFebruary 11, 2000
K944379regulatory and marketing servicesORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAGFebruary 15, 1995
K944384regulatory and marketing servicesORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAGFebruary 15, 1995
K944378regulatory and marketing servicesORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAGFebruary 15, 1995