Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (K241853)
Description
Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve by Varian Medical Systems, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241853
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. Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (K241853) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K120731 | TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY | Varian Medical Systems, Inc. | 2012 |
| K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS | Varian Medical Systems | 2003 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | 2025 |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | 2025 |
Trace the full predicate network for K241853
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.