Natrelle 133S Tissue Expanders
FDA 510(k) clearance K254126 · decided 2026-01-16
Clearance details
- K-number
- K254126
- Device name
- Natrelle 133S Tissue Expanders
- Applicant
- AbbVie
- Decision
- Substantially Equivalent
- Date received
- 2025-12-19
- Decision date
- 2026-01-16
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LCJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963) | Mentor Worldwide, LLC | 2025-04-24 |
| Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (K243836) | Mentor Worldwide, LLC | 2025-01-12 |
| MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (K241918) | Mentor Worldwide, LLC | 2024-08-02 |
| Motiva Flora SmoothSilk Tissue Expander (K211676) | Motiva USA, LLC | 2023-10-13 |
| AlloX2 Pro Tissue Expanders (K214124) | Sientra, Inc. | 2023-06-08 |
| Sientra, inc. Portfinder (K221127) | Sientra, Inc. | 2023-05-10 |
| Natrelle 133 Plus MICROCELL Tissue Expander (K180826) | Allergan | 2018-12-21 |
| CPX 4 Breast Tissue Expander with Smooth Surface (K182335) | Mentor Worldwide, LLC | 2018-09-25 |
| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| Unger Quad Injector (K161483) | Stradis Healthcare | 2016-10-31 |
| ARTOURA Breast Tissue Expanders with Smooth Surface (K161176) | Mentor Worldwide, LLC | 2016-05-23 |
| CPX 4 Breast Tissue Expander (K152496) | Mentor Worldwide, LLC | 2016-02-19 |
Recalls involving this device
No recalls on record reference this clearance.