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510(k) K954795

AT2 & DOYLE STYLE (C-FLEX) VENT TUBES by Trebay Medical Corp. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1995
Date Received
October 18, 1995
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

Other clearances by Trebay Medical Corp.

  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955560 — TREBAY SCOPE IRRIGATED CLEARING SLEEVE (December 22, 1995)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K955447 — TYMPANOSTOMY TUBE (December 21, 1995)
  • K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (December 6, 1995)
  • K954796 — MICRO-INGRESSOR HANDIPIECE (November 6, 1995)
  • K954715 — MICRO-PLANER HANDPIECE (October 27, 1995)
  • K954518 — TREBAY TOTAL RECTANGULAR HEAD (October 27, 1995)
  • K954517 — TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT (October 27, 1995)
  • K952226 — C-FLEX SEPTAL SPLINTS (August 11, 1995)

Other clearances for product code ETD

  • K250256 — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube (April 28, 2025)
  • 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)