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510(k) K851652

PAPILLOTOME by Microvasive — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1985
Date Received
April 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Microvasive

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  • K861323 — REPLACEMENT GASTROSTOMY TUBE (December 16, 1986)
  • K861309 — JEJUNAL FEEDING TUBE (December 16, 1986)
  • K860589 — INFLATOR/DEFLATOR PISTON SYRINGE (April 7, 1986)
  • K860366 — CHALLENGER HOT BIOPSY FORCEPS (April 7, 1986)
  • K854238 — NEEDLE W/STYLET FOR IMPLANTATION (November 13, 1985)
  • K854063 — MICROVASIVE SILICONE SPRAY (October 25, 1985)
  • K850393 — FLEXIBLE FIBEROPTIC ENDOSCOPE (June 4, 1985)
  • K844769 — RIGID FIBEROPITC ENDOSCOPE (January 15, 1985)

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