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510(k) K946019

SURGICLA INSTRUMENT KIT by Medical Action Industries, Inc. — Product Code FRG

K946019 is an FDA 510(k) premarket notification submitted by Medical Action Industries, Inc. for the device "SURGICLA INSTRUMENT KIT". The FDA issued a decision of Substantially Equivalent on March 20, 1995. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Medical Action Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1995
Date Received
December 12, 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 Medical Action Industries, Inc.

  • K042526 — DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON S (April 25, 2005)
  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)
  • K022948 — VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L (November 4, 2002)
  • K923846 — BURN DRESSING (September 11, 1992)
  • K884826 — GAUZE SPONGE (December 22, 1988)
  • K810685 — SUTURE REMOVAL KIT (March 26, 1981)
  • K810184 — LAPAROTOMY SPONGE (February 4, 1981)

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