Home / 510(k) Clearances / K990703

510(k) K990703

SPOROX II STERILIZING & DISINFECTING SOLUTION by Reckitt Benckiser, Inc. — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1999
Date Received
March 4, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type

Other clearances by Reckitt Benckiser, Inc.

  • K173504 — K-Y Silicone (January 12, 2018)
  • K151884 — K-Y Marilyn Pleasure Gel (January 11, 2016)
  • K143532 — Durex Silicone (July 31, 2015)
  • K143511 — K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant (May 20, 2015)
  • K131643 — DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT (December 17, 2014)
  • K140193 — DUREX EMBRACE PERSONAL LUBRICANT (November 4, 2014)
  • K970230 — SPOROX (October 29, 1997)
  • K963353 — LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) (October 18, 1996)

Other clearances for product code MED

  • K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liq (October 3, 2023)
  • K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (March 28, 2023)
  • K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 28, 2022)
  • K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 7, 2021)
  • K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (May 12, 2021)
  • K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (December 10, 2019)
  • K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (September 5, 2019)
  • K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem (March 22, 2019)
  • K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (January 31, 2019)
  • K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System (April 4, 2018)