Data / Medical devices / China / Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd

Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance

Name: Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd is registered with the FDA (registration 3007675948) in Hangzhou Zhejiang, China. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 1991. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007675948
Address: No. 100 Sangyuan Rd Hangzhou Tonglu EconomicDevelopment Zone, Hangzhou Zhejiang, China, 311501
Owner or operator: Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. (10046214)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: February 18, 2014
Registered through: 2026
Brand names listed: SurgyCut Grasping Forceps, SugyCut Biopsy Forceps

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Hemostat, Surgical	EMD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Irrigator, Sinus	KAR	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Knife, Surgical	EMF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Pliers, Surgical	HTC	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Stripper, Vein, Disposable	GAJ	1	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 29, 1991	K911316	INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA	GEI	Substantially Equivalent	Northgate Technologies, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 29, 1991. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.