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510(k) K834467

SPECIMEN TRAP by Microvasive — Product Code BYZ

K834467 is an FDA 510(k) premarket notification submitted by Microvasive for the device "SPECIMEN TRAP". The FDA issued a decision of Substantially Equivalent on February 17, 1984. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Microvasive has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1984
Date Received
December 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trap, Sterile Specimen
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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)
  • K850393 — FLEXIBLE FIBEROPTIC ENDOSCOPE (June 4, 1985)

Other clearances for product code BYZ

  • K925412 — ELECTROMEDICS TISSUE TRAP/ #TT280 (February 5, 1993)
  • K913643 — MUCOUS SPECIMEN TRAP (October 10, 1991)
  • K902883 — TISSUE/POLYP TRAP SYSTEM (September 12, 1990)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K840253 — ONE-WAY AIR VALVE (April 5, 1984)
  • K822557 — SPECIMEN ADAPTOR (October 18, 1982)
  • K822556 — CRITICAL MEASUREMENT UNIT (October 18, 1982)
  • K791847 — ASPRI-LUKE (October 2, 1979)

FDA data resources