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510(k) K945106

MICROMED TOTAL REGULAR AND PARTIAL OFFSET by Micromed Development Corp. — Product Code ETA

K945106 is an FDA 510(k) premarket notification submitted by Micromed Development Corp. for the device "MICROMED TOTAL REGULAR AND PARTIAL OFFSET". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Micromed Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
October 18, 1994
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 Micromed Development Corp.

  • K945105 — POLY/PLATINUM WIRE PISTON (May 14, 1996)
  • K945831 — DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT (January 20, 1995)
  • K945242 — NERVE MONITOR ELECTRODES/STIMULATOR PROBES (December 27, 1994)
  • K945108 — POLY PISTON (November 22, 1994)
  • K945438 — EDI-BUR MICRODRILL SYSTEMS (November 22, 1994)
  • K945104 — MICROMED PARTIAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
  • K945107 — POLY-WIRE PISTON (November 22, 1994)
  • K943848 — COLLAR BUTTON VENTURI VENT TUBE (September 16, 1994)
  • K943847 — BOBBIN STYLE VENTURI VENT TUBE (September 2, 1994)
  • K943849 — GROMMENT STYLE VENTURI TUBE (September 2, 1994)

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

FDA data resources