AART GLUTEAL IMPLANT— 510(k) K021839

Clearance details

Applicant

Aesthetic and Reconstructive Technologies, Inc.

Product code

Code MIB

Device class

Class 2

Regulation

21 CFR 874.3620

Advisory panel

Ear, Nose, Throat

Date received

2002-06-04

Decision date

2002-07-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Paso Robles, CA, US

• K241150 — MISTI Silicone Implant2024-07-24
• K223051 — Pre-Formed Silicone Block2023-02-03
• K222748 — ShiNeo Silicone Implant2022-12-23
• K200073 — AugMENTA Penile Implant2022-09-30
• K220760 — Pre-Formed Penile Silicone Block2022-05-13

• K023678 — DIMISIL SCAR GEL2003-01-23
• K022306 — AART SILICONE TUBING2002-10-10
• K022511 — AART CALF IMPLANT2002-08-26
• K022223 — AART SILICONE SHEETING2002-08-08
• K021820 — AART SILICONE CARVING BLOCK2002-07-16

Injury

146

Total

146

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0945-2026 — 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 code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-105 - Gluteal Implant style 1 size 5 UDI-DI code: B490501105 501-206 - Gluteal Implant style 2 size 6 UDI-DI code: B490501206 501-301 - Gluteal Implant style 3 size 1 UDI-DI code: B490501301 501-302 - Gluteal Implant style 3 size 2 UDI-DI code: B490501302 501-303 - Gluteal Implant style 3 size 3 UDI-DI code: B490501303 501-304 - Gluteal Implant style 3 size 4 UDI-DI code: B490501304 501-305 - Gluteal Implant style 3 size 5 UDI-DI code: B490501305 501-306 - Gluteal Implant style 3 size 6 UDI-DI code: B490501306 501-307 - Gluteal Implant style 3 size 7 UDI-DI code: B490501307 501-309 - Gluteal Implant style 3 size 9 UDI-DI code: B490501309 501-310 - Gluteal Implant style 3 size 10 UDI-DI code: B490501310Class II·Ongoing·DSAART LLC·20250926

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021839.