MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
FDA 510(k) clearance K130813 · decided 2013-04-11
Clearance details
- K-number
- K130813
- Device name
- MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
- Applicant
- Mentor Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-25
- Decision date
- 2013-04-11
- Days to decision
- 17 days
- Clearance type
- Special
- Product code
- LCJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Natrelle 133S Tissue Expanders (K254126) | AbbVie | 2026-01-16 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 35 recall (Z-1681-2026) | Mentor Texas, LP. | 2026-03-27 |
| CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breas recall (Z-2781-2016) | Mentor Texas, LP. | 2016-09-10 |
| MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Sut recall (Z-2747-2016) | Mentor Texas, LP. | 2016-09-07 |
| MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Sut recall (Z-2748-2016) | Mentor Texas, LP. | 2016-09-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S084) | Mentor Corp. | 2025-12-17 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S080) | Mentor Corp. | 2025-08-12 |
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S082) | Mentor Corp. | 2025-08-08 |
| Mentor MemoryGel® Breast Implants (P030053/S072) | Mentor Corp. | 2025-08-06 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S077) | Mentor Corp. | 2025-07-03 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S081) | Mentor Corp. | 2025-06-18 |
| MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053/S079) | Mentor Corp. | 2025-05-21 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S078) | Mentor Corp. | 2025-02-14 |