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510(k) K850393

FLEXIBLE FIBEROPTIC ENDOSCOPE by Microvasive

K850393 is an FDA 510(k) premarket notification submitted by Microvasive for the device "FLEXIBLE FIBEROPTIC ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on June 4, 1985. Microvasive has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1985
Date Received
February 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Microvasive

  • K872771 — LOW PROFILE GASTROSTOMY (October 9, 1987)
  • K870705 — THERMAL COAGULATOR (April 17, 1987)
  • K861323 — REPLACEMENT GASTROSTOMY TUBE (December 16, 1986)
  • K861309 — JEJUNAL FEEDING TUBE (December 16, 1986)
  • K860366 — CHALLENGER HOT BIOPSY FORCEPS (April 7, 1986)
  • K860589 — INFLATOR/DEFLATOR PISTON SYRINGE (April 7, 1986)
  • K854238 — NEEDLE W/STYLET FOR IMPLANTATION (November 13, 1985)
  • K854063 — MICROVASIVE SILICONE SPRAY (October 25, 1985)
  • K851652 — PAPILLOTOME (June 24, 1985)
  • K844769 — RIGID FIBEROPITC ENDOSCOPE (January 15, 1985)

FDA data resources