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510(k) K923120

MICROGUIDE LESION MARKING SYSTEM by Angiodynamics, Div. E-Z-Em, Inc. — Product Code GDF

K923120 is an FDA 510(k) premarket notification submitted by Angiodynamics, Div. E-Z-Em, Inc. for the device "MICROGUIDE LESION MARKING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 1, 1992. The device falls under product code GDF (Guide, Needle, Surgical), a Class I device regulated under 21 CFR 878.4800. Angiodynamics, Div. E-Z-Em, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1992
Date Received
June 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Angiodynamics, Div. E-Z-Em, Inc.

  • K961763 — PULSE*SPRAY INFUSION SYSTEM (July 17, 1996)
  • K951509 — PULSE*SPRAY INFUSION SYSTEM (June 16, 1995)
  • K951602 — PULSE*SPRAY INFUSION SYSTEM (June 14, 1995)
  • K950907 — PULSE*SPRAY INFUSION SYSTEM (May 17, 1995)
  • K933846 — ANGIOGRAPHY SYRINGE KITS (December 13, 1994)

Other clearances for product code GDF

  • K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 (July 23, 2003)
  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K945124 — BREAST LESION LOCALIZATION NEEDLE (November 22, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)

FDA data resources