Home / 510(k) Clearances / K222440

510(k) K222440

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays by Steris — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2022
Date Received
August 12, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Steris

  • K251452 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (June 6, 2025)
  • K242773 — Electro Lube NXT (April 15, 2025)
  • DEN230085 — VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (November 12, 2024)
  • K242189 — CELERITY HP Indicator Tape (PCC077) (August 20, 2024)
  • K241344 — MetriCide™ OPA Plus Solution Test Strip (June 11, 2024)
  • K241055 — Electro Lube NXT (May 31, 2024)
  • K240760 — CELERITY HP Indicator Tape (April 10, 2024)
  • K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810) (March 8, 2024)
  • K233654 — VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Ste (December 8, 2023)
  • K233187 — Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) (October 27, 2023)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)