Home / 510(k) Clearances / K912132

510(k) K912132

OPERAND LUBRICATING JELLY by General Medical Co. — Product Code FHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1991
Date Received
May 14, 1991
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 General Medical Co.

  • K926269 — PROCEDURE KIT (August 27, 1993)
  • K912975 — OPERAND LUBRICATING JELLY (September 27, 1991)
  • K903669 — GENESIS INSUFFLATING CATHETER (September 12, 1990)
  • K900110 — OPERAND* LUBRICATING JELLY (May 2, 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 FHX

  • K081990 — LUBRICANO STERILE GEL (December 5, 2008)
  • K951713 — BUTTON LUBRICATOR (April 25, 1995)
  • K935548 — CATHEJELL S STERILE LUBRICATING JELLY (March 30, 1994)
  • K780386 — K-Y LUBRICATING JELLY (April 13, 1978)
  • K771364 — LUBE JEL (August 2, 1977)