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510(k) K830298

ACCU-LINE SURGICAL MARKER by Accu-Line — Product Code FZZ

K830298 is an FDA 510(k) premarket notification submitted by Accu-Line for the device "ACCU-LINE SURGICAL MARKER". The FDA issued a decision of Substantially Equivalent on June 2, 1983. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660. Accu-Line has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1983
Date Received
January 28, 1983
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 Accu-Line

  • K831847 — JEJUNOSTOMY KIT (August 31, 1983)
  • K831636 — PERCUTANEOUS INTRODUCER KIT (August 24, 1983)
  • K831637 — ACCU-FLUSH (June 30, 1983)

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