Product code FGM— Gastroenterology, Urology

FDA has cleared 7 devices under product code FGM between 1995 and 2004, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20041 clearance
• 20031 clearance
• 20011 clearance
• 20001 clearance
• 19953 clearances

• Regulatory & Marketing Services, Inc.3 clearances
• Uromed Corp.2 clearances
• Blue Torch Medical Technologies2 clearances

• K041732 — CAVERMAP SURGICAL AIDBlue Torch Medical Technologies·2004-09-21
• K031527 — MODIFICATION TO CAVERMAP SURGICAL AIDBlue Torch Medical Technologies·2003-06-05
• K010098 — MODIFICATION TO CAVERMAP SURGICAL AIDUromed Corp.·2001-02-01
• K993436 — CAVERMAP SURGICAL AIDUromed Corp.·2000-02-11
• K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.·1995-02-15
• K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.·1995-02-15
• K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAGRegulatory & Marketing Services, Inc.·1995-02-15