510(k) K132889 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
| Applicant | Nucletron B.V., Veenendaal, NL |
| Decision | Substantially Equivalent, Feb 26, 2014 |
| Received | Sep 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | Elekta, Inc. Brand Name: Fletcher CT/MR Shielded Applicator Set
Product Name: Intracavitary Remote Afterloading Applicator
Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecologi Open, Classified |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.