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510(k) K951431

AQUAGEL LUBRICATING JELLY by Depuy Healthcare — Product Code KMJ

K951431 is an FDA 510(k) premarket notification submitted by Depuy Healthcare for the device "AQUAGEL LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on July 21, 1995. 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
July 21, 1995
Date Received
March 27, 1995
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

  • 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)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)

FDA data resources