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510(k) K241565

Sterilization Package/Reel by Anqing Clean Dental Instrument Technology Co., Ltd. — Product Code FRG

K241565 is an FDA 510(k) premarket notification submitted by Anqing Clean Dental Instrument Technology Co., Ltd. for the device "Sterilization Package/Reel". The FDA issued a decision of Substantially Equivalent on February 24, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2025
Date Received
May 31, 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

  • K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HE (July 2, 2026)
  • K252823 — Dukal Crepe Paper Sterilization Wrap (May 28, 2026)
  • K253454 — HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; (May 18, 2026)
  • 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)

FDA data resources