Home / 510(k) Clearances / K993234

510(k) K993234

MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Micromedics, Inc. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1999
Date Received
September 27, 1999
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 Micromedics, Inc.

  • K241739 — Endoscopic Applicator, 41 cm (July 15, 2024)
  • K123847 — MALLEABLE TIP ENDOSCOPIC APPLICATOR (January 8, 2013)
  • K122526 — 360 GAS ASSISTED ENDOSCOPIC APPLICATOR (November 16, 2012)
  • K120608 — ENDOSCOPIC APPLICATOR (March 15, 2012)
  • K102563 — SINGLE CANNULA EXTENDED APPLICATOR (March 15, 2011)
  • K100754 — GRAFT DELIVERY SYSTEM MODEL SA-6115 (June 9, 2010)
  • K073401 — EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (March 14, 2008)
  • K061092 — BAXTER DUPLOSPRAY MIS APPLICATOR (September 13, 2006)
  • K051157 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS (September 1, 2005)
  • K050340 — MICROMEDICS SPHENOID SINUS STENT (April 27, 2005)

Other clearances for product code ETB

  • 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)
  • K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (November 24, 2003)
  • K021479 — CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 (May 21, 2002)