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510(k) K934682

SURGICAL VIDEO CAMERA AND ACCESSORIES by Medical Dynamics, Inc. — Product Code FWF

K934682 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "SURGICAL VIDEO CAMERA AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 15, 1994. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1994
Date Received
September 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Television, Endoscopic, Without Audio
Device Class
Class I
Regulation Number
878.4160
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)
  • 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)
  • K904113 — OPERATIVE RECORDING CAMERA (October 30, 1990)

Other clearances for product code FWF

  • K053412 — FLEXISCOPE, MODELS 50MH AND 50 MHC (February 23, 2006)
  • K990154 — KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM (June 1, 1999)
  • K982754 — EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N ( (January 8, 1999)
  • K982965 — ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES (November 23, 1998)
  • K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (September 10, 1998)
  • K982409 — VES 1501-M (August 21, 1998)
  • K981819 — ANGIOLAZ VES-1CAM (August 4, 1998)
  • K944707 — ISOLATED CAMERA HEAD (October 7, 1994)
  • K930297 — FUJINON VIDEO LAPAROSCOPE, MODIFIED (March 29, 1994)
  • K932628 — ENDOSCOPIC VIDEO CAMERA (October 15, 1993)

FDA data resources