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510(k) K083189

STERI-LUB LUBRICATION GEL by Avail Medical Products, Inc. — Product Code KMJ

K083189 is an FDA 510(k) premarket notification submitted by Avail Medical Products, Inc. for the device "STERI-LUB LUBRICATION GEL". The FDA issued a decision of Substantially Equivalent on November 21, 2008. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Avail Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2008
Date Received
October 29, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Patient
Device Class
Class I
Regulation Number
880.6375
Review Panel
HO
Submission Type

Other clearances by Avail Medical Products, Inc.

  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)
  • 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 KMJ

  • K142473 — Lubricating Jelly (April 13, 2015)
  • K141028 — COLONGLIDE LUBRICANT (July 24, 2014)
  • K131617 — COLONGLIDE(R) LUBRICANT (October 3, 2013)
  • K121390 — LUBE JELLY SURINGE (August 10, 2012)
  • K113689 — DUKAL LUBRICATING JELLY (May 4, 2012)
  • K112110 — STERILE LUBRICATING JELLY (April 10, 2012)
  • K103718 — DYNACOR LUBRICATION GEL (May 10, 2011)
  • K101522 — ULTRA SEAL STERILE LUBRICATING JELLY (December 23, 2010)
  • K092488 — DYNAREX STERILE LUBRICATING JELLY (December 18, 2009)
  • K073684 — SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (May 22, 2008)

FDA data resources