Class Class II
Self-Forming Magnet (Flexagon Plus OTOLoc) (K250541)
Description
Self-Forming Magnet (Flexagon Plus OTOLoc) by Gi Windows, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250541
Clearance Date2025-08-01
Clearance TypeTraditional
Product CodeSAH
Regulation Number878.4816
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250541
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. Self-Forming Magnet (Flexagon Plus OTOLoc) (K250541) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243482 | Self-Forming Magnet (Flexagon) | GI Windows, Inc. | 2025 |
| K043115 | LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) | Niti Medical Technologies , Ltd. | 2004 |
Trace the full predicate network for K250541
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.