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510(k) K930568

ADAIR/VERESS NEEDLE INTRODUCER SET by Medical Dynamics, Inc. — Product Code GCB

K930568 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "ADAIR/VERESS NEEDLE INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code GCB (Needle, Catheter), a Class I device regulated under 21 CFR 878.4200. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Medical Dynamics, Inc.

  • K974542 — TRUE VISION, TRUE VISION II (February 17, 1998)
  • K921294 — VIDEO ENDOSCOPE-RIGID MODIFICATION (July 20, 1994)
  • K934682 — SURGICAL VIDEO CAMERA AND ACCESSORIES (February 15, 1994)
  • K915538 — OVER THE WIRE STONE BASKET (March 20, 1992)
  • K914315 — OPTICAL CATHETER INTRODUCER SETS, MODIFICATION (March 4, 1992)
  • K913986 — CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM (January 28, 1992)
  • K911296 — OPTICAL CATHETER ARTHROSCOPE (September 24, 1991)
  • K903339 — VIDEO ENDOSCOPE, RIGID (March 6, 1991)
  • K904609 — XENON LIGHT SOURCE (December 18, 1990)
  • K904113 — OPERATIVE RECORDING CAMERA (October 30, 1990)

Other clearances for product code GCB

  • K150800 — Valved Safety Centesis Catheter (November 12, 2015)
  • K974146 — PARACENTESIS CATHETER DEVICE (January 28, 1998)
  • K923028 — TURKEL PNEUMOTHORAX KIT (August 4, 1992)
  • K900374 — ADAIR/VERESS NEEDLE INTRODUCER SET (April 20, 1990)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)

FDA data resources