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U.S. Surgitech, Inc.: FDA-registered device maker in Carol Stream, IL, United States, 1 510(k) clearance

Name: U.S. Surgitech, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

U.S. Surgitech, Inc. is registered with the FDA (registration 3004777218) in Carol Stream, IL, United States. It lists 12 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: 3004777218
Address: 551 Kimberly Drive, Carol Stream, IL, United States, 60188
Owner or operator: U.S. SURGITECH, INC. (9067640)
Roles: Repackager or relabeler, Specification developer
First device listed: February 3, 2018
Registered through: 2026
Brand names listed: SurgyCut Biopsy Forceps, SurgyCut Grasping Forceps

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Specification developer	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Repackager or relabeler	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Repackager or relabeler	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Specification developer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Repackager or relabeler	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Specification developer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Specification developer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Support, Patient Position	CCX	1	Specification developer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Repackager or relabeler, Specification developer	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.