Home / 510(k) Clearances / K243431

510(k) K243431

Medicom Sterilization Pouch and Reel by Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
November 5, 2024
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 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)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)
  • K240438 — CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (4 (November 4, 2024)