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510(k) K221379

Steriking LT-Blueline Pouches with Tyvek by Wipak OY — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2023
Date Received
May 12, 2022
Clearance Type
Traditional
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 Wipak OY

  • K232625 — Steriking® Pouch for Robotic Instruments (June 7, 2024)
  • K231996 — Steriking® LT-Blueline Pouches with Tyvek® (September 7, 2023)
  • K231999 — Steriking® LT-Blueline Pouches with Tyvek® (September 7, 2023)
  • K221377 — SteriKing LT-Blueline Pouches with Tyvek (December 22, 2022)
  • K221016 — Steriking Packaging for Medical Devices (May 5, 2022)
  • K210810 — Steiking Packaging for Medical Devices (January 23, 2022)

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)