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510(k) K232059

Tympanostomy Tubes by Grace Medical, Inc. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2023
Date Received
July 11, 2023
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 Grace Medical, Inc.

  • K161376 — DragonFly Surgical Drill System (August 25, 2016)
  • K091187 — GRACE DYNAMIC TORP (September 14, 2009)
  • K080070 — K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (April 17, 2008)
  • K063374 — NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, (December 6, 2006)
  • K062672 — GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES (October 24, 2006)
  • K062385 — BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES (September 27, 2006)
  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
  • K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES (June 28, 2006)
  • K991394 — STAPES PROSTHESES (May 18, 1999)
  • K981575 — TYMPANOSTOMY TUBE (July 15, 1998)

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)
  • 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)
  • K133921 — PRECEPTIS TYMPANOSTOMY TUBE INSERTER (August 22, 2014)