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510(k) K780956

OTOLOGICAL VENTILATION TUBES by Mcghan Medical Corp. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1978
Date Received
June 9, 1978
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 Mcghan Medical Corp.

  • K873475 — MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS (September 11, 1987)
  • K873476 — MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS (September 11, 1987)
  • K870754 — MCGHAN TISSUE EXPANDER FILL SYSTEM (March 31, 1987)
  • K864185 — MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN (December 24, 1986)
  • K864184 — MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN (December 24, 1986)
  • K862203 — MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER (July 23, 1986)
  • K854794 — MCGHAN INTEGRAL VALVE TISSUE EXPANDER (December 24, 1985)
  • K853014 — MCGHAN TISSUE EXPANDER FILL KIT (September 18, 1985)
  • K843704 — MCGHAN TISSUE EXPANDER (October 31, 1984)
  • K781087 — MEDICAL GRADE SILICONE ELASTOMER TUBING (November 22, 1978)

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)