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510(k) K052298

CYSTOGLIDE INTRODUCER SHEATH by Percutaneous Systems, Incorporated — Product Code KNY

K052298 is an FDA 510(k) premarket notification submitted by Percutaneous Systems, Incorporated for the device "CYSTOGLIDE INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on December 12, 2006. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Percutaneous Systems, Incorporated has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2006
Date Received
August 23, 2005
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 Percutaneous Systems, Incorporated

  • K090485 — COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 (July 22, 2009)
  • K061766 — EXPRESSWAY INTERMITTENT CATHETER (March 9, 2007)
  • K052048 — ACCORDION (September 13, 2005)
  • K042531 — UPDATED SLIP UROLOGY INTRODUCER SHEATH (February 1, 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)

FDA data resources