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510(k) K926166

COAST VIDEO ENDOSCOPIC IMAGING SYSTEM by Optik — Product Code FWF

K926166 is an FDA 510(k) premarket notification submitted by Optik for the device "COAST VIDEO ENDOSCOPIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 1, 1993. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Optik has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1993
Date Received
December 8, 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 by Optik

  • K933776 — OPTIK LAPAROSCOPE (March 16, 1994)
  • K896404 — TITAMED ANTWERP SYSTEM (April 16, 1990)
  • K896589 — MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP (December 27, 1989)
  • K894558 — MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET (August 7, 1989)
  • K894557 — LIGHTSCOPE SET (August 7, 1989)

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