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510(k) K012931

GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM by Allegiance Healthcare Corp. — Product Code FRG

K012931 is an FDA 510(k) premarket notification submitted by Allegiance Healthcare Corp. for the device "GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 20, 2002. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Allegiance Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2002
Date Received
August 31, 2001
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 Allegiance Healthcare Corp.

  • K023673 — AIRLIFE DEMAND NASAL CANNULA (May 2, 2003)
  • K023419 — TRILAMINATE DRAPES/TIBURON (February 11, 2003)
  • K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES (January 15, 2003)
  • K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN (January 9, 2003)
  • K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (December 18, 2002)
  • K023425 — DRAPES WITH ABSORBENT REINFORCEMENT (November 6, 2002)
  • K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 11, 2002)
  • K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 9, 2002)
  • K023167 — BREATHABLE SURGICAL GOWN (October 2, 2002)
  • K020818 — POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (July 5, 2002)

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