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510(k) K923160

3DSCOPE by American Surgical Technologies Corp. — Product Code FWF

K923160 is an FDA 510(k) premarket notification submitted by American Surgical Technologies Corp. for the device "3DSCOPE". The FDA issued a decision of Substantially Equivalent on December 10, 1992. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1992
Date Received
June 29, 1992
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 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)
  • K934682 — SURGICAL VIDEO CAMERA AND ACCESSORIES (February 15, 1994)

FDA data resources