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510(k) K182144

Bi-Flex Evo by Promepla Sam — Product Code KNY

K182144 is an FDA 510(k) premarket notification submitted by Promepla Sam for the device "Bi-Flex Evo". The FDA issued a decision of Substantially Equivalent on September 7, 2018. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Promepla Sam has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2018
Date Received
August 8, 2018
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 Promepla Sam

  • K173734 — RocaJJ Soft Stents (March 12, 2018)
  • K152278 — ENDOFLOW II - Irrigation, Warming and Suction System (February 9, 2016)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)

Other clearances for product code KNY

  • 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)
  • K052298 — CYSTOGLIDE INTRODUCER SHEATH (December 12, 2006)

FDA data resources