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510(k) K820302

SURGIPEEL SELF-SEAL PACKAGING SYSTEM by Surgicot, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1982
Date Received
February 4, 1982
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 Surgicot, Inc.

  • K962605 — PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) (March 11, 1997)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K863122 — ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. (December 17, 1986)
  • K855101 — ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR (July 17, 1986)
  • K854631 — ASSERT EO BIOLOGICAL TEST PACK (May 27, 1986)
  • K854902 — SURGICOT STEAM TEST PACK (May 20, 1986)
  • K840541 — NEURO SPONGE (April 23, 1984)
  • K840471 — EYE SPEAR (March 16, 1984)
  • K840470 — SURGISCRIBE MARKING PEN (March 12, 1984)
  • K830739 — PRO-GUARD (March 29, 1983)

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)