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510(k) K112209

PREFILLED CATHETER INFLATION SYRINGE by Avail Medical Products, Inc. — Product Code KNY

K112209 is an FDA 510(k) premarket notification submitted by Avail Medical Products, Inc. for the device "PREFILLED CATHETER INFLATION SYRINGE". The FDA issued a decision of Substantially Equivalent on September 8, 2011. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Avail Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2011
Date Received
August 1, 2011
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 Avail Medical Products, Inc.

  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)
  • K030149 — MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, (March 20, 2003)
  • K030137 — MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, (February 19, 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)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)
  • K052298 — CYSTOGLIDE INTRODUCER SHEATH (December 12, 2006)

FDA data resources