Class Class II
ReShape Calibration Tubes (K230131)
Description
ReShape Calibration Tubes by Reshape Lifesciences, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230131
Clearance Date2023-02-15
Clearance TypeSpecial
Product CodeKNT
Regulation Number876.5980
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230131
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. ReShape Calibration Tubes (K230131) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | 2022 |
Trace the full predicate network for K230131
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.