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510(k) K000801

PC COATED FLUOROPLASTIC VENT TUBES by Gyrus Ent LLC — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2000
Date Received
March 13, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tympanostomy
Device Class
Class II
Regulation Number
874.3880
Review Panel
EN
Submission Type

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  • K033089 — HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM (February 5, 2004)
  • K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (November 24, 2003)
  • K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING IN (May 2, 2003)
  • K021595 — GYRUS ENT NERVE STIMULATOR (October 24, 2002)
  • K021777 — GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND P (August 26, 2002)
  • K020778 — GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 (May 28, 2002)
  • K020067 — GYRUS ENT SOMNOPLASTY GENERATOR (April 4, 2002)
  • K020594 — DIEGO POWERED DISSECTOR AND DRILL SYSTEM (March 8, 2002)

Other clearances for product code ETD

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  • K232702 — Solo+ Tympanostomy Tube Device (TTD) (May 20, 2024)
  • K233658 — Biowy Tym Tube (TT) (February 16, 2024)
  • K232059 — Tympanostomy Tubes (November 24, 2023)
  • K221254 — Hummingbird Tympanostomy Tube System (July 27, 2022)
  • K200952 — Hummingbird Tympanostomy Tube System (June 5, 2020)
  • K171239 — TULA Tube Delivery System (June 28, 2017)
  • K151830 — Hummingbird Tympanostomy Tube (September 21, 2015)
  • K151067 — Ventilation (Tympanostomy) Tubes (July 22, 2015)
  • K142282 — HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) (April 23, 2015)