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510(k) K894319

MEDICAL DYNAMICS LIGHT SOURCE by Medical Dynamics, Inc. — Product Code FSW

K894319 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "MEDICAL DYNAMICS LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on October 3, 1989. The device falls under product code FSW (Light, Surgical, Endoscopic), a Class II device regulated under 21 CFR 878.4580. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1989
Date Received
July 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Endoscopic
Device Class
Class II
Regulation Number
878.4580
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)
  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • 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)

Other clearances for product code FSW

  • K022989 — RADLITE TISSUE RETRACTOR SYSTEM (November 25, 2002)
  • K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (February 1, 2002)
  • K943342 — MEDICAM XENON LIGHT SOURCE (October 17, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)
  • K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT (September 2, 1992)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K870898 — ULTRA-LUX LIGHT SOURCE (March 18, 1987)

FDA data resources