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510(k) K862564

A.C.L. GUIDE KIT by Aspen Laboratories, Inc. — Product Code FZX

K862564 is an FDA 510(k) premarket notification submitted by Aspen Laboratories, Inc. for the device "A.C.L. GUIDE KIT". The FDA issued a decision of Substantially Equivalent on August 18, 1986. The device falls under product code FZX (Guide, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Aspen Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1986
Date Received
July 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Aspen Laboratories, Inc.

  • K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT (April 21, 1998)
  • K963088 — SHEATH, ELECTROSURGICAL PENCIL (September 13, 1996)
  • K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT (July 11, 1996)
  • K960296 — 4000 ETM (February 20, 1996)
  • K953081 — BEAMER PLUS (October 30, 1995)
  • K953007 — EXCALIBUR PLUS ELECTROSURGICAL UNIT (August 21, 1995)
  • K946104 — SMOKIEVAC ELECTROSURGICAL PENCIL (April 3, 1995)
  • K944012 — ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR (December 21, 1994)
  • K924960 — EXCALIBUR ELECTROSURGICAL UNIT (April 16, 1993)
  • K913213 — SINGLE USE LEE ELECTRODE (February 13, 1992)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K871413 — CIVCO STEPPER (July 14, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (December 24, 1985)
  • K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (July 11, 1985)
  • K842698 — BRITISH SPINAL FUSION SET (September 12, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)
  • K841297 — TECHMEDICA DRILL GUIDE (April 25, 1984)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)

FDA data resources