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510(k) K242839

Safe Secure Sterilization Pouches and Rolls by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2024
Date Received
September 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

  • K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeS (December 23, 2025)
  • K213358 — Surgical Mask (March 4, 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)