Class Class II
PUMA-G Pediatric System (K242211)
Description
PUMA-G Pediatric System by Coaptech, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242211
Clearance Date2025-04-29
Clearance TypeTraditional
Product CodeKGC
Regulation Number876.5980
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242211
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. PUMA-G Pediatric System (K242211) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223916 | PUMA-G System | Coaptech, Inc. | 2023 |
Trace the full predicate network for K242211
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.