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FDA 510(k)

DIMPLO Implant System

K-Number: K251605 · 2025-12-22

ApplicantDIMPLO, Ltd.
Decision Date2025-12-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIMPLO Implant System is a medical device manufactured by DIMPLO, Ltd.. It received FDA 510(k) clearance on 2025-12-22 under approval number K251605. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMPLO Implant System?

DIMPLO Implant System is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by DIMPLO, Ltd.. The 510(k) number is K251605.

When was DIMPLO Implant System approved by the FDA?

DIMPLO Implant System received FDA 510(k) clearance on 2025-12-22, under approval number K251605.

What company makes DIMPLO Implant System?

DIMPLO Implant System is manufactured by DIMPLO, Ltd..

What is the FDA product code for DIMPLO Implant System?

The FDA product code for DIMPLO Implant System is DZE.

Related Clinical Trials

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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