Class Class II
Pre-Formed Silicone Block (K223051)
Description
Pre-Formed Silicone Block by International Medical Devices, Inc., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223051
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeMIB
Regulation Number874.3620
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223051
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. Pre-Formed Silicone Block (K223051) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2022 |
| K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019 |
| K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017 |
| K042380 | SILICONE BLOCK | National Medical Devices, Inc. | 2004 |
Trace the full predicate network for K223051
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.