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510(k) K152291

Sterisheet Sterilization Wrap by Andersen Sterilizers, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
August 13, 2015
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 Andersen Sterilizers, Inc.

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  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K200335 — Sterisheet Sterilization Wrap (November 12, 2020)
  • K200336 — Tyvek Sterilization Pouches with Chevron Seal (November 12, 2020)
  • K200334 — AN1036 Dosimeter (November 12, 2020)
  • K192980 — EOGas 4 Endo-SteriTest (November 12, 2020)
  • K170439 — AN87 Dosimeter (November 1, 2017)
  • K170437 — Sterisheet Sterilization Wrap (November 1, 2017)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)

Other clearances for product code FRG

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  • 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)