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510(k) K915682

STERRAD 100 STERILIZATION SYSTEM by Johnson & Johnson Medical, Inc. — Product Code FLF

K915682 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "STERRAD 100 STERILIZATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 1993. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1993
Date Received
December 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Johnson & Johnson Medical, Inc.

  • K033523 — COLLAGEN-ORC ANTIMICROBIAL MATRIX (October 21, 2004)
  • K022483 — ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING (February 3, 2003)
  • K014129 — PROMOGRAN MATRIX WOUND DRESSING (February 14, 2002)
  • K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (July 31, 2000)
  • K982641 — ADVANCED NIBP MODULE (March 29, 1999)
  • K983362 — NU-GEL * WOUND DRESSING (December 16, 1998)
  • K982597 — FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (August 20, 1998)
  • K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF (May 18, 1998)
  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
  • K972498 — OBSERVER * CENTRAL STATION (February 17, 1998)

Other clearances for product code FLF

  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)
  • K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 18, 2015)
  • K142034 — 3M STERI-VAC STERILIZER/AERATOR (January 8, 2015)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (August 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)

FDA data resources