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510(k) K043375

FISCH TITANIUM MIDDLE EAR PROSTHESES by Karl Storz Endoscopy — Product Code ETA

K043375 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "FISCH TITANIUM MIDDLE EAR PROSTHESES". The FDA issued a decision of Substantially Equivalent on January 24, 2005. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Karl Storz Endoscopy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2005
Date Received
December 8, 2004
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 Karl Storz Endoscopy

  • K030848 — PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (June 2, 2003)
  • K030009 — KSEA POWERSHAVER SYSTEM S2 (April 2, 2003)
  • K023924 — AUTOCON II 200 ELECTROSURGICAL GENERATOR (February 21, 2003)
  • K023187 — KSEA SPINOSCOPE (December 2, 2002)
  • K011700 — MODULITH SLK LITHOTRIPTER (August 16, 2002)
  • K021776 — KSEA QUADRO SWITCH (August 15, 2002)
  • K013107 — BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (February 26, 2002)
  • K011841 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (September 10, 2001)
  • K010569 — KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (April 9, 2001)
  • K004037 — X-RAY SYSTEM XR-MX (February 2, 2001)

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)
  • 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)
  • K002378 — MODULAR PORP AND TORP MODEL TBD (August 29, 2000)
  • 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