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510(k) K261142

Device
Ponto 5 Mini; Ponto 5 Superpower
Applicant
Oticon Medical AB
510(k) number
K261142
Product code
MAH
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-26
Date received
2026-04-07
Regulation
874.3302
Classification name
Hearing Aid, Bone Conduction, Implanted
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Anders Johansson
Address
Datavägen 37 B Askim SE 43632 43632

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB2021-03-03
K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas2018-12-19
K152820Ponto Bone Anchored Hearing SystemOticon Medical AB2016-01-22
K152067Ponto bone anchored hearing systemOticon Medical AB2015-11-23
K150555BA400 14mm AbutmentCochlear Americas2015-07-15
K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mmOticon Medical AB2015-01-21
K121317COCHLEAR BAHA IMPLANT SYSTEMCochlear Americas2012-10-12
K121228PONTO BONE ANCHORED HEARING SYSTEMOticon Medical AB2012-09-07
K112053OBC BONE ANCHORED HEARING SYSTEMOticon Medical AB2011-11-18
K080363BAHA CORDELLE IICochlear Bone Anchored Systems AB2008-04-10
K984162BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USENobelpharma USA, Inc.1999-06-28