510(k) K161176
- Device
- ARTOURA Breast Tissue Expanders With Smooth Surface
- Applicant
- MENTOR WORLDWIDE LLC
- 510(k) number
- K161176
- Product code
- LCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-23
- Date received
- 2016-04-26
- Regulation
- 510(k) Premarket Notification
- Classification name
- Expander, Skin, Inflatable
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURA C. VELLUCCI
- Address
- 33 Technology Dr. Irvin CA US 92618 92618
FDA Registration Numbers#
- 1720929
- 3017636737
- 2183744
- 9681387
- 8043385
- 1645337
- 2011068
- 3012883202
- 3010055973
- 3005423519
- 3013764800
- 1424263
- 3005288183
- 9617229
- 2521402
- 1649518
- 3009976880
- 2182979
- 3014279513
- 3018544165
- 2523676
- 3003915875
- 9614279
Source Documents#
Other 510(k) Records For Product Code LCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | 2026-01-16 |
| K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC | 2025-04-24 |
| K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2025-01-12 |
| K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2024-08-02 |
| K211676 | Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC | 2023-10-13 |
| K214124 | AlloX2 Pro Tissue Expanders | Sientra, Inc. | 2023-06-08 |
| K221127 | Sientra, inc. Portfinder | Sientra, Inc. | 2023-05-10 |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | 2018-12-21 |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC | 2018-09-25 |
| K182054 | Natrelle 133S Tissue Expander | Allergan | 2018-08-29 |
| K161483 | Unger Quad Injector | Stradis Healthcare | 2016-10-31 |
| K152496 | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | 2016-02-19 |
| K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015-08-20 |
| K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | 2015-04-24 |
| K142998 | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | 2014-12-19 |
Legacy Summary#
summary
FDA Review#
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