Class Class II
Altis Single Incision Sling System (K221874)
Description
Altis Single Incision Sling System by Coloplast A/S, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221874
Clearance Date2023-02-15
Clearance TypeSpecial
Product CodePAH
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221874
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. Altis Single Incision Sling System (K221874) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K121562 | ALTIS SINGLE INCISION CLING SYSTEM | Coloplast A/S | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242473 | Altis Single Incision Sling System (519650); Aris Transobtu... | Coloplast Corp. | 2024 |
Trace the full predicate network for K221874
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.