510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191457Substantially Equivalent

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

Med-el Elektromedizinische Geraete, GmbH, Innsbruck, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K191457 is the FDA 510(k) clearance record for BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm), a class II device, cleared for Med-El Elektromedizinische Geraete GmbH on under FDA product code PFO (Active Implantable Bone Conduction Hearing System). FDA's definition for product code PFO reads: "An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is...". FDA records list 6 510(k) clearances for Med-El Elektromedizinische Geraete GmbH, from to . As of , FDA records show no recalls naming K191457.

Clearance record

Decision date
Received
(110 days to decision)
Product code
PFO Active Implantable Bone Conduction Hearing System
Regulation
21 CFR 874.3340
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Med-El Elektromedizinische Geraete GmbH Fuestenweg 77a, Innsbruck, AT
510(k) summary
Statement
Third party review
No

Clearances, product code PFO

Trailing 12 months
1 clearance under product code PFO in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PFO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260