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510(k) K042531

UPDATED SLIP UROLOGY INTRODUCER SHEATH by Percutaneous Systems, Incorporated — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2005
Date Received
September 17, 2004
Clearance Type
Special
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 Percutaneous Systems, Incorporated

  • K090485 — COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 (July 22, 2009)
  • K061766 — EXPRESSWAY INTERMITTENT CATHETER (March 9, 2007)
  • K052298 — CYSTOGLIDE INTRODUCER SHEATH (December 12, 2006)
  • K052048 — ACCORDION (September 13, 2005)

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)