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510(k) K832540

DRUMTO STAPES PROSTHESIS by Humboldt Products — Product Code ETB

K832540 is an FDA 510(k) premarket notification submitted by Humboldt Products for the device "DRUMTO STAPES PROSTHESIS". The FDA issued a decision of Substantially Equivalent on January 3, 1984. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Humboldt Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
July 29, 1983
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 Humboldt Products

  • K823483 — STAINLESS STEEL PISTONS (December 9, 1982)
  • K813616 — TEKNA MED MYRINGOTOMY DISPOS-OTO KIT (January 22, 1982)
  • K812562 — SURGICAL RETRACTOR & ELASTIC STAYS, DISP (October 2, 1981)
  • K802587 — OTOLOGICAL VENTILATION TUBES (November 12, 1980)

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