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510(k) K761254

BAND-AGE ICE-BANDAGE by Surgicot, Inc. — Product Code ILO

K761254 is an FDA 510(k) premarket notification submitted by Surgicot, Inc. for the device "BAND-AGE ICE-BANDAGE". The FDA issued a decision of Substantially Equivalent on February 24, 1977. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Surgicot, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1977
Date Received
December 13, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
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 ILO

  • K213097 — Armory Motion (June 10, 2022)
  • K083008 — COOLSKIN (June 10, 2009)
  • K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
  • K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE (September 7, 2007)
  • K070402 — MODIFICATION TO POLAR CARE 500 (March 29, 2007)
  • K040317 — IVC SYSTEM (May 7, 2004)
  • K973023 — INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET (November 3, 1997)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)
  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)

FDA data resources