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510(k) K001404

GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON by Mednet Locator, Inc. — Product Code ETA

K001404 is an FDA 510(k) premarket notification submitted by Mednet Locator, Inc. for the device "GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON". The FDA issued a decision of Substantially Equivalent on August 8, 2000. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Mednet Locator, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2000
Date Received
May 3, 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 Mednet Locator, Inc.

  • K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (August 8, 2000)
  • K974174 — ULTRABUR (March 10, 1998)
  • K972735 — TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) (September 5, 1997)
  • K972737 — CAUSSE PISTON (September 5, 1997)
  • K972734 — PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) (September 5, 1997)
  • K972126 — MYRINGOTOMY TUBE (July 29, 1997)
  • K972400 — MYRINGOTOMY TUBE - BOBBIN WITH TAB (July 23, 1997)
  • K971943 — MYRINGOTOMY TUBE (July 23, 1997)

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)
  • K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (August 8, 2000)
  • K001902 — BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (July 10, 2000)

FDA data resources