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510(k) K092488

DYNAREX STERILE LUBRICATING JELLY by Dynarex Corporation — Product Code KMJ

K092488 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "DYNAREX STERILE LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on December 18, 2009. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Dynarex Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2009
Date Received
August 13, 2009
Clearance Type
Traditional
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 Dynarex Corporation

  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K152970 — Dynarex Xeroform Petrolatum Dressing (October 3, 2016)
  • K151575 — Dynarex Eye Cups (September 1, 2015)
  • K103086 — DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC (June 7, 2011)
  • K102637 — DYNAREX ULTRASOUND GEL (February 16, 2011)
  • K082863 — DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING S (January 9, 2009)
  • K081569 — DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR US (September 12, 2008)

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)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)
  • K073684 — SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (May 22, 2008)

FDA data resources