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510(k) K860366

CHALLENGER HOT BIOPSY FORCEPS by Microvasive — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1986
Date Received
February 3, 1986
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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  • K870705 — THERMAL COAGULATOR (April 17, 1987)
  • K861323 — REPLACEMENT GASTROSTOMY TUBE (December 16, 1986)
  • K861309 — JEJUNAL FEEDING TUBE (December 16, 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)
  • K850393 — FLEXIBLE FIBEROPTIC ENDOSCOPE (June 4, 1985)
  • K844769 — RIGID FIBEROPITC ENDOSCOPE (January 15, 1985)

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