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510(k) K771364

LUBE JEL by Travenol Laboratories, S.A. — Product Code FHX

K771364 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "LUBE JEL". The FDA issued a decision of Substantially Equivalent on August 2, 1977. The device falls under product code FHX (Jelly, Lubricating, For Transurethral Surgical Instrument), a Class II device regulated under 21 CFR 876.1500. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1977
Date Received
July 25, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Jelly, Lubricating, For Transurethral Surgical Instrument
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

Other clearances for product code FHX

  • K081990 — LUBRICANO STERILE GEL (December 5, 2008)
  • K951713 — BUTTON LUBRICATOR (April 25, 1995)
  • K935548 — CATHEJELL S STERILE LUBRICATING JELLY (March 30, 1994)
  • K912132 — OPERAND LUBRICATING JELLY (August 7, 1991)
  • K780386 — K-Y LUBRICATING JELLY (April 13, 1978)

FDA data resources