ESTABLISHMENT LABS S.A.

FDA Device Registration & Listing · Coyol Alajuela, CR · Registration 3012883202

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012883202
FEI Number
3012883202
Entity Name
ESTABLISHMENT LABS S.A.
City/State/Country
Coyol Alajuela, CR
Establishment Address
Coyol Free Zone & Business Park Building, 4th Street, Building B-15, Coyol Alajuela 20113, CR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Establishment Labs- Motiva USA LLC (Owner Number: 10061559)
Owner / Operator Contact Address
125 E. De la Guerra #203A, Santa Barbara, CA 93101, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K183163
PMA Number
N/A

All Registered Proprietary Names

Motiva SmoothSilk Round and SmoothSilk Ergonomix Breast Implants Motiva Inflatable Balloon Motiva Flora SmoothSilk Tissue Expander Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix®

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled General, Plastic Surgery Class 3 878.3540 2024-09-27
FZW Expander, Surgical, Skin Graft General, Plastic Surgery Class 1 878.4800 2025-06-02
LCJ Tissue Expander And Accessories Unknown Class U N/A 2023-11-15
MRD Mammary Sizer Unknown Class U N/A 2019-10-29

Official Correspondent

No official correspondent registered.

US Agent Details

Rosalyn D'incelli Business: Motiva USA LLC Email: c-rdincelli@establishmentlabs.com Phone: (805) 4525421

Related Public Records

Same Entity

Establishment Labs- Motiva USA LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K161483 Stradis Healthcare Unger Quad Injector 2016-10-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-04 N/A 3
McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012883202. Last updated year: 2026. Please use registration number 3012883202 when referencing this establishment in official correspondence.
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