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510(k) K212198

Tyvek(R) Roll with CI for STERLINKTM Sterilizer by Plasmapp Co,., Ltd. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2021
Date Received
July 14, 2021
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 Plasmapp Co,., Ltd.

  • K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK (May 25, 2023)
  • K223015 — STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (May 9, 2023)
  • K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (May 9, 2023)
  • K223025 — Tyvek Roll with CI for STERLINK Sterilizer (May 9, 2023)
  • K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE (April 14, 2023)
  • K212200 — STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (October 22, 2021)
  • K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (October 22, 2021)

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)