FDA product code LCJ: Tissue Expander And Accessories
LCJ is the FDA product code for tissue expander and accessories. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 55 510(k) submissions under LCJ, 7 in the last five years, from 26 different applicants. The average 510(k) review took 142 days (median 71); 60 days on average over the last three years. FDA has posted 21 recalls for LCJ devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tissue Expander And Accessories |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LCJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 108 |
| 2023 | 3 | 592 |
| 2024 | 1 | 32 |
| 2025 | 2 | 120 |
| 2026 | 1 | 28 |
Compare with all 510(k) review times · Search every LCJ clearance
Top LCJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mentor Corp. | 9 | 2013-04-11 |
| Mentor Worldwide, LLC | 8 | 2025-04-24 |
| Mcghan Medical Corp. | 7 | 1987-03-31 |
| Specialty Surgical Products, Inc. | 3 | 2014-10-28 |
| Sientra, Inc. | 2 | 2023-06-08 |
21 more applicants have LCJ clearances. See the full list in Caduvo.
Most recent LCJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254126 | AbbVie | Natrelle 133S Tissue Expanders | 2026-01-16 | 28 |
| K242963 | Mentor Worldwide, LLC | MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs | 2025-04-24 | 211 |
| K243836 | Mentor Worldwide, LLC | Mentor CPX 4 PLUS Enhance Breast Tissue Expander | 2025-01-12 | 30 |
| K241918 | Mentor Worldwide, LLC | MENTOR CPX4 PLUS Enhance Breast Tissue Expander | 2024-08-02 | 32 |
| K211676 | Motiva USA, LLC | Motiva Flora SmoothSilk Tissue Expander | 2023-10-13 | 864 |
Recalls for LCJ devices
21 product recalls in 7 recall events; 11 initiated in the last five years and 15 still open. Most recent: 2026-02-18.
| Year | Recalls |
|---|---|
| 2019 | 4 |
| 2023 | 1 |
| 2026 | 10 |
Frequently asked questions
What is FDA product code LCJ?
LCJ is the FDA product code for tissue expander and accessories. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is LCJ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCJ?
Across 55 cleared submissions the average was 142 days from receipt to decision (median 71).
Which companies have the most LCJ clearances?
Mentor Corp. (9); Mentor Worldwide, LLC (8); Mcghan Medical Corp. (7); Specialty Surgical Products, Inc. (3); Sientra, Inc. (2).
Have LCJ devices been recalled?
Yes: 21 product recalls across 7 recall events; the most recent began 2026-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code LCJ
- Run a recall and safety report across every LCJ manufacturer
- Watch product code LCJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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