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510(k) K900110

OPERAND* LUBRICATING JELLY by General Medical Co. — Product Code KMJ

K900110 is an FDA 510(k) premarket notification submitted by General Medical Co. for the device "OPERAND* LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on May 2, 1990. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. General Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1990
Date Received
January 9, 1990
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 General Medical Co.

  • K926269 — PROCEDURE KIT (August 27, 1993)
  • K912975 — OPERAND LUBRICATING JELLY (September 27, 1991)
  • K912132 — OPERAND LUBRICATING JELLY (August 7, 1991)
  • K903669 — GENESIS INSUFFLATING CATHETER (September 12, 1990)
  • K853635 — SUBDERM TM (December 20, 1985)
  • K844652 — C.A.S.E. CONTAINER (December 12, 1984)
  • K831320 — DRIONIC (July 19, 1983)
  • K820689 — C.S.R. WRAPPERS (April 9, 1982)
  • K820521 — STERILIZATION WRAP (March 18, 1982)
  • K802231 — AIR VIVA II (October 10, 1980)

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