Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007675948

FEI Number

3007675948

Entity Name

HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENT CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No. 100 Sangyuan Rd, Hangzhou Tonglu EconomicDevelopment Zone, Hangzhou Zhejiang 311501, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. (Owner Number: 10046214)

Owner / Operator Contact Address

No. 100, Sangyuan Road, Tonglu Economic Development Zone, Tonglu, CN-ZJ 311501, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2014-02-18
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-02-18
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2025-01-02
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2014-02-18
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2014-02-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2014-02-18
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-02-18
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2014-02-18
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-02-18
GAJ	Stripper, Vein, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-02-18
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2014-02-18

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd.

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
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007675948. Last updated year: 2026. Please use registration number 3007675948 when referencing this establishment in official correspondence.