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510(k) K840470

SURGISCRIBE MARKING PEN by Surgicot, Inc. — Product Code FZZ

K840470 is an FDA 510(k) premarket notification submitted by Surgicot, Inc. for the device "SURGISCRIBE MARKING PEN". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660. Surgicot, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
February 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Skin
Device Class
Class I
Regulation Number
878.4660
Review Panel
SU
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)
  • K830739 — PRO-GUARD (March 29, 1983)
  • K820302 — SURGIPEEL SELF-SEAL PACKAGING SYSTEM (February 24, 1982)

Other clearances for product code FZZ

  • K042555 — SURGICHIP TAG SURGICAL MARKER (November 9, 2004)
  • K915066 — DISPOSABLE SKIN MARKER (May 14, 1992)
  • K914759 — BLOOM TRANSPARENT STENCIL (April 21, 1992)
  • K912730 — ROCKET SURGICAL SKIN MARKING PEN (November 7, 1991)
  • K905143 — SKIN MARKER (February 6, 1991)
  • K904559 — QUALTEX SKIN MARKER (December 13, 1990)
  • K896792 — SURGICAL SKIN MARKER (December 27, 1989)
  • K864371 — SURGICAL SKIN MARKER (November 17, 1986)
  • K863280 — DERMAMARKER (September 9, 1986)
  • K861772 — LASER SKIN MARKER AND MASK WHITE LOTION (May 21, 1986)

FDA data resources