Class Class II
Delta III Pro (K221903)
Description
Delta III Pro by Dornier Medtech America, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221903
Clearance Date2023-02-22
Clearance TypeTraditional
Product CodeLNS
Regulation Number876.5990
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221903
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Delta III Pro (K221903) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201074 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2020 |
Trace the full predicate network for K221903
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.