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510(k) K233777

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) by Primed Medical Products, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2024
Date Received
November 24, 2023
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 Primed Medical Products, Inc.

  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (October 7, 2024)
  • K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks (August 26, 2024)
  • K213427 — PRIMED Pediatric Facemask (November 22, 2022)
  • K160361 — PRIMAGARD Isolation Gown (AAMI PB70 Level 3) (November 4, 2016)
  • K092012 — PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL (September 25, 2009)
  • K081633 — PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS (August 11, 2008)

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)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)