Data / Medical devices / United States / Atc Technologies Inc.

Atc Technologies Inc.: FDA-registered device maker in Wilmington, MA, United States, 5 510(k) clearances

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

Atc Technologies Inc. is registered with the FDA (registration 1225798) in Wilmington, MA, United States. It lists 15 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 14, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1225798
FEI number: 3001595430
Address: 30-B Upton Drive, Wilmington, MA, United States, 01887
Owner or operator: ATC Technologiess Inc. (10027340)
Roles: Contract manufacturer, Manufacturer
First device listed: October 27, 2008
Registered through: 2026
Brand names listed: Modulap, Moduloop, Sparrowhawk

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Nephrostomy	LJE	U	Contract manufacturer	accessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	KNF	2	Manufacturer	accessdata.fda.gov
Device, Biopsy, Endomyocardial	DWZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	2	Contract manufacturer	accessdata.fda.gov
Endoscopic Tissue Approximation Device	OCW	2	Contract manufacturer	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Contract manufacturer	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Contract manufacturer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lens, Condensing, Diagnostic	HJL	1	Contract manufacturer	accessdata.fda.gov
Lens, Contact, Polymethylmethacrylate, Diagnostic	HJK	2	Contract manufacturer	accessdata.fda.gov
Prism, Gonioscopic	HKS	1	Contract manufacturer	accessdata.fda.gov
Tonometer, Manual	HKY	2	Contract manufacturer	accessdata.fda.gov
Topical Approximation System	MZR	1	Contract 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
June 14, 2013	K121343	MODULAP LOOP	KNF	Substantially Equivalent	Atc Technologies, Inc.	accessdata.fda.gov
June 6, 2001	K010473	SPARROWHAWK DISPOSABLE	DWZ	Substantially Equivalent	Atc Technologies, Inc.	accessdata.fda.gov
March 20, 2000	K994319	MODULAP	GEI	Substantially Equivalent	Atc Technologies, Inc.	accessdata.fda.gov
December 18, 1998	K983623	MODULAP	GCJ	Substantially Equivalent	Atc Technologies, Inc.	accessdata.fda.gov
September 8, 1998	K982445	MODULAP	GCJ	Substantially Equivalent	Atc Medical Technology, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 14, 2013. 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.