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510(k) K243367

Device
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
Applicant
Minnesota Medical Technologies
510(k) number
K243367
Product code
PBP
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-22
Date received
2024-10-30
Regulation
876.5980
Classification name
Rectal Insert
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Robert Anglin
Address
2446 Henry Rd. NW Stewartville MN US 55976 55976

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PBP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K122003RENEW INSERTRenew Medical, Inc.2012-10-26