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510(k) K944378

ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG by Regulatory & Marketing Services, Inc. — Product Code FGM

K944378 is an FDA 510(k) premarket notification submitted by Regulatory & Marketing Services, Inc. for the device "ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG". The FDA issued a decision of Substantially Equivalent on Feb 15, 1995. The device falls under product code FGM (Probe And Director, Gastro-Urology), a Class I device regulated under 21 CFR 876.4730. Regulatory & Marketing Services, Inc. has 21 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 15, 1995
Date Received
Sep 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe And Director, Gastro-Urology
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type
510(k) Exempt

Other clearances by Regulatory & Marketing Services, Inc.

  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (Mar 24, 2011)
  • K944673 — MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE (Apr 10, 1996)
  • K954752 — PEDIATRIC EUROPHYLIC FOLEY CATHETER (Oct 30, 1995)
  • K941342 — PAIN DOC (Oct 13, 1995)
  • K941543 — DIAL MEDICAL KIT (Feb 16, 1995)
  • K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (Feb 15, 1995)
  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (Feb 15, 1995)
  • K945874 — EUROMEDICAL POLY TRACHEOTOMY TUBE (Dec 27, 1994)
  • K944383 — ORION RED URETHRAL CATHETER (Dec 6, 1994)
  • K944377 — ORION'S URINARY DRAINAGE SET (Dec 6, 1994)

Other clearances for product code FGM

  • K041732 — CAVERMAP SURGICAL AID (Sep 21, 2004)
  • K031527 — MODIFICATION TO CAVERMAP SURGICAL AID (Jun 5, 2003)
  • K010098 — MODIFICATION TO CAVERMAP SURGICAL AID (Feb 1, 2001)
  • K993436 — CAVERMAP SURGICAL AID (Feb 11, 2000)
  • K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (Feb 15, 1995)
  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (Feb 15, 1995)

FDA data resources