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510(k) K142473

Lubricating Jelly by Sion Biotext Medical , Ltd. — Product Code KMJ

K142473 is an FDA 510(k) premarket notification submitted by Sion Biotext Medical , Ltd. for the device "Lubricating Jelly". The FDA issued a decision of Substantially Equivalent on April 13, 2015. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2015
Date Received
September 3, 2014
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 for product code KMJ

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

FDA data resources