Chrysalis Intelligence · Product Codes · LCJ

LCJ · Tissue Expander And Accessories

Unknown · 7 clearances · 4 unique sponsors

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Device class
Unclassified
Regulation —
Total clearances
7
2023-05-10 → 2026-01-16
Last 12 months
1
Unique sponsors
4
Classification details
Medical specialty
Unknown
Review panel
SU
Regulation number
—
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Mentor Worldwide, LLC 3 0 2025-04-24
Sientra, Inc. 2 0 2023-06-08
AbbVie 1 1 2026-01-16
Motiva USA, LLC 1 0 2023-10-13
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-01-16 K254126 AbbVie Natrelle 133S Tissue Expanders
2025-04-24 K242963 Mentor Worldwide, LLC MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
2025-01-12 K243836 Mentor Worldwide, LLC Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander
2024-08-02 K241918 Mentor Worldwide, LLC MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
2023-10-13 K211676 Motiva USA, LLC Motiva Flora SmoothSilk Tissue Expander
2023-06-08 K214124 Sientra, Inc. AlloX2 Pro Tissue Expanders
2023-05-10 K221127 Sientra, Inc. Sientra, inc. Portfinder
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence