FULWELL LLC

FDA Device Registration & Listing · Miami, FL, US · Registration 3010131466

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
3010131466
FEI Number
3010131466
Entity Name
FULWELL LLC
City/State/Country
Miami, FL, US
Establishment Address
3411 NW 48 STREET, Miami, FL 33142, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Fulwell LLC (Owner Number: 10043857)
Owner / Operator Contact Address
3411 NW 48 STREET, Miami, FL 33142, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K102372
PMA Number
N/A

All Registered Proprietary Names

FORCEPS, BIOPSY, NON-ELECTRIC Electrosurgical, cutting & coagulation & accessories Electrosurgical, cutting & coagulation & accessories Electrosurgical, cutting & coagulation & accessories

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2013-03-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-06-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-03-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-03-29

Official Correspondent

Xi Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fulwell 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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010131466. Last updated year: 2026. Please use registration number 3010131466 when referencing this establishment in official correspondence.
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