510(k) K021839 ยท MIB Elastomer, Silicone Block
AART GLUTEAL IMPLANT
| Applicant | Aesthetic and Reconstructive Technologies, Inc., Paso Robles CA, US |
| Decision | Substantially Equivalent, Jul 16, 2002 |
| Received | Jun 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021839
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | DSAART LLC Brand Name: AART Gluteal Implant
Product Name: Gluteal Implant
Model/Catalog Numbers:
501-101 - Gluteal Implant style 1 size 1
UDI-DI code: B490501101
501-103 - Gluteal Implant style 1 size 3
UDI-DI Open, Classified |
MIB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.