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510(k) K051593

UROPASS URETERAL ACCESS SHEATH, MODEL 61224 by Acmi Corporation — Product Code KNY

K051593 is an FDA 510(k) premarket notification submitted by Acmi Corporation for the device "UROPASS URETERAL ACCESS SHEATH, MODEL 61224". The FDA issued a decision of Substantially Equivalent on September 2, 2005. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Acmi Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2005
Date Received
June 16, 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 Acmi Corporation

  • K061975 — PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK (August 10, 2006)
  • K060752 — ACMI DUR-HL LASER SYSTEMS (May 25, 2006)
  • K060269 — ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM (March 31, 2006)
  • K052044 — ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL (August 16, 2005)
  • K043581 — DUAL LUMEN CATHETER (March 3, 2005)
  • K042069 — INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM (November 1, 2004)
  • K042225 — ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (September 10, 2004)
  • K031758 — ACMI M4 TELESCOPES (September 2, 2003)
  • K030960 — ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE (July 16, 2003)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (June 23, 2003)

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