Home / 510(k) Clearances / K935643

510(k) K935643

SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE by Regulatory & Marketing Services, Inc. — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1994
Date Received
November 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Regulatory & Marketing Services, Inc.

  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (March 24, 2011)
  • K944673 — MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE (April 10, 1996)
  • K954752 — PEDIATRIC EUROPHYLIC FOLEY CATHETER (October 30, 1995)
  • K941342 — PAIN DOC (October 13, 1995)
  • K941543 — DIAL MEDICAL KIT (February 16, 1995)
  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (February 15, 1995)
  • K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K945874 — EUROMEDICAL POLY TRACHEOTOMY TUBE (December 27, 1994)
  • K944383 — ORION RED URETHRAL CATHETER (December 6, 1994)

Other clearances for product code KNY

  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)