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510(k) K140441

BI-FLEX URETERAL ACCESS SHEATH by Promepla Sam — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2014
Date Received
February 21, 2014
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 Promepla Sam

  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K173734 — RocaJJ Soft Stents (March 12, 2018)
  • K152278 — ENDOFLOW II - Irrigation, Warming and Suction System (February 9, 2016)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)

Other clearances for product code KNY

  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • 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)
  • K052298 — CYSTOGLIDE INTRODUCER SHEATH (December 12, 2006)