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510(k) K941466

SURGICAL INSTRUMENTS KIT by Clinical Resources, Inc. — Product Code FRG

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 22, 1994
Date Received
March 28, 1994
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 Clinical Resources, Inc.

  • K941470 — TRACHEOSTOMY CARE KIT (February 14, 1995)
  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K944881 — SKIN SCRUB TRAY (December 27, 1994)
  • K944879 — GAUZE SPONGES (December 23, 1994)
  • K945021 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K945019 — FLUFF GAUXZE ROLL (December 23, 1994)
  • K945020 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K944880 — BODILY FLUID DISPOSAL KIT (December 15, 1994)
  • K941467 — WOUND DRESSING KIT (May 12, 1994)
  • K941471 — CENTRAL LINE DRESSING CHANGE TRAY (May 12, 1994)

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)