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510(k) K971943

MYRINGOTOMY TUBE by Mednet Locator, Inc. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1997
Date Received
May 27, 1997
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 Mednet Locator, Inc.

  • K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GO (August 8, 2000)
  • K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (August 8, 2000)
  • K974174 — ULTRABUR (March 10, 1998)
  • K972735 — TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) (September 5, 1997)
  • K972737 — CAUSSE PISTON (September 5, 1997)
  • K972734 — PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) (September 5, 1997)
  • K972126 — MYRINGOTOMY TUBE (July 29, 1997)
  • K972400 — MYRINGOTOMY TUBE - BOBBIN WITH TAB (July 23, 1997)

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)