Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)

K-Number: K243367 · 2025-07-22

ApplicantMinnesota Medical Technologies
Decision Date2025-07-22
Product CodePBP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is a medical device manufactured by Minnesota Medical Technologies. It received FDA 510(k) clearance on 2025-07-22 under approval number K243367. The device is classified under product code PBP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is a medical device that received FDA 510(k) clearance on 2025-07-22. It is manufactured by Minnesota Medical Technologies. The 510(k) number is K243367.

When was Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) approved by the FDA?

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) received FDA 510(k) clearance on 2025-07-22, under approval number K243367.

What company makes Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is manufactured by Minnesota Medical Technologies.

What is the FDA product code for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?

The FDA product code for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is PBP.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07604415 Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence RECRUITING NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT04115605 A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence TERMINATED

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41860549 FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications. JAMA network open (2026)

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.

↑