Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012744132

FEI Number

3012744132

Entity Name

FRACTYL HEALTH, INC.

City/State/Country

Burlington, MA, US

Establishment Address

3 Van de Graaff Drive, Suite 200, Burlington, MA 01803, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Fractyl Health, Inc. (Owner Number: 10057639)

Owner / Operator Contact Address

3 Van de Graaff Drive, Suite 200, Burlington, MA 01803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Revita System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MIK	Device, Ultrasonic, Thermal Ablation	Unknown	Class 3	N/A	2018-05-07

Official Correspondent

Jonathan Fitzgerald

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fractyl Health, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012744132. Last updated year: 2026. Please use registration number 3012744132 when referencing this establishment in official correspondence.