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510(k) K002378

MODULAR PORP AND TORP MODEL TBD by Gyrus Ent LLC — Product Code ETA

K002378 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "MODULAR PORP AND TORP MODEL TBD". The FDA issued a decision of Substantially Equivalent on August 29, 2000. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Gyrus Ent LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2000
Date Received
August 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacement, Ossicular Prosthesis, Total
Device Class
Class II
Regulation Number
874.3495
Review Panel
EN
Submission Type

Other clearances by Gyrus Ent LLC

  • K040996 — RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING (August 20, 2004)
  • K034004 — DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE (March 3, 2004)
  • 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 ETA

  • K260719 — mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (5869 (April 3, 2026)
  • K241269 — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO To (January 17, 2025)
  • K091187 — GRACE DYNAMIC TORP (September 14, 2009)
  • K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL0 (March 23, 2009)
  • K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES (January 24, 2005)
  • K042503 — KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (October 1, 2004)
  • K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM (March 3, 2003)
  • K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (August 8, 2000)
  • K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GO (August 8, 2000)
  • K001902 — BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (July 10, 2000)

FDA data resources