AART PECTORALIS IMPLANT— 510(k) K021337

Clearance details

Applicant

Aesthetic and Reconstructive Technologies, Inc.

Product code

Code MIC

Device class

Class 2

Regulation

21 CFR 874.3620

Advisory panel

Ear, Nose, Throat

Date received

2002-04-26

Decision date

2002-07-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Paso Robles, CA, US

• K002633 — SILMAX PECTORAL IMPLANT2000-11-21
• K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT1998-09-30
• K983043 — SEARE BIOMEDICAL SILICONE BLOCK1998-09-30
• K973729 — POWERFLEX PEC IMPLANT1997-12-24
• K961072 — PEC IMPLANT1996-04-19

• 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

• Z-0948-2026 — Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6Class II·Ongoing·DSAART LLC·20250926

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021337.