Ponto Bone Anchored Hearing System, MONO Surgery Kit— 510(k) K203807

Name: FDA 510(k) clearance K203807
Creator: U.S. Food and Drug Administration
Published: 2021-03-03

Substantially Equivalent

Oticon Medical AB

FDA 510(k) clearance K203807 for Ponto Bone Anchored Hearing System, MONO Surgery Kit, Substantially Equivalent on 2021-03-03. Applicant: Oticon Medical AB. Device class: 2.

Clearance details

Applicant: Oticon Medical AB
Product code: Code MAH
Device class: Class 2
Regulation: 21 CFR 874.3302
Advisory panel: Ear, Nose, Throat
Date received: 2020-12-28
Decision date: 2021-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Askim, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAH

view all

K261142 — Ponto 5 Mini; Ponto 5 Superpower2026-08-26
K182116 — BA310 Abutment, BIA310 Implant/Abutment2018-12-19
K152820 — Ponto Bone Anchored Hearing System2016-01-22
K152067 — Ponto bone anchored hearing system2015-11-23
K150555 — BA400 14mm Abutment2015-07-15

More clearances from Oticon Medical AB

view all

K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS2024-07-10
K213733 — Ponto 5 SuperPower2021-12-16
K211640 — Ponto 5 Mini2021-08-10
K190540 — Ponto 42019-05-02
K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPower2016-09-29

Adverse events under product code MAH

product code MAH

Injury: 4,155
Total: 4,155

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.