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510(k) K101522

ULTRA SEAL STERILE LUBRICATING JELLY by Ultra Seal Corporation — Product Code KMJ

K101522 is an FDA 510(k) premarket notification submitted by Ultra Seal Corporation for the device "ULTRA SEAL STERILE LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on December 23, 2010. 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
December 23, 2010
Date Received
June 2, 2010
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)
  • 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