U.S. SURGITECH, INC.

FDA Device Registration & Listing · Carol Stream, IL, US · Registration 3004777218

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
3004777218
FEI Number
3004777218
Entity Name
U.S. SURGITECH, INC.
City/State/Country
Carol Stream, IL, US
Establishment Address
551 Kimberly Drive, Carol Stream, IL 60188, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
U.S. SURGITECH, INC. (Owner Number: 9067640)
Owner / Operator Contact Address
551 Kimberly Drive, Carol Stream, IL 60188, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SurgyCut Grasping Forceps SurgyCut Biopsy Forceps

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2018-02-03
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2025-12-24
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2026-06-16
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2024-09-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-02-01
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2025-12-24
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-08-29

Official Correspondent

MAAZ MEAH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

U.S. SURGITECH, INC.
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 3004777218. Last updated year: 2026. Please use registration number 3004777218 when referencing this establishment in official correspondence.
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