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510(k) K945104

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

K945104 is an FDA 510(k) premarket notification submitted by Micromed Development Corp. for the device "MICROMED PARTIAL REGULAR AND PARTIAL OFFSET". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. 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
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
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)
  • K945107 — POLY-WIRE PISTON (November 22, 1994)
  • K945106 — MICROMED TOTAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
  • K945438 — EDI-BUR MICRODRILL SYSTEMS (November 22, 1994)
  • K945108 — POLY PISTON (November 22, 1994)
  • K943848 — COLLAR BUTTON VENTURI VENT TUBE (September 16, 1994)
  • K943849 — GROMMENT STYLE VENTURI TUBE (September 2, 1994)
  • K943847 — BOBBIN STYLE VENTURI VENT TUBE (September 2, 1994)

Other clearances for product code ETB

  • K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x (April 3, 2026)
  • K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (5 (April 3, 2026)
  • K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis (January 17, 2025)
  • K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFI (January 17, 2025)
  • K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES P (December 2, 2013)
  • K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS (February 8, 2013)
  • 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)
  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
  • K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES (June 28, 2006)

FDA data resources