FDA.report

510(k) K260314

Device
Ancora-SB
Applicant
Aspero Medical, Inc.
510(k) number
K260314
Product code
FDA
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-01
Date received
2026-01-30
Regulation
876.1500
Classification name
Enteroscope And Accessories
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Mark Rentschler
Address
10835 Dover St. Suite 800 Westminster CO US 80021 80021

FDA Registration Numbers

Source Documents

510(k) summary PDF

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