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Lacey Manufacturing Company LLC: FDA-registered device maker in Bridgeport, CT, United States, 5 510(k) clearances

Name: Lacey Manufacturing Company LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lacey Manufacturing Company LLC is registered with the FDA (registration 1218017) in Bridgeport, CT, United States. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 10, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1218017
Address: 1146 Barnum Ave, Bridgeport, CT, United States, 06610
Owner or operator: PARAGON MEDICAL, INC. (1218017)
Roles: Contract manufacturer, Manufacturer
First device listed: April 5, 2012
Registered through: 2026
Brand names listed: BEST Bipolar Forceps, Boston Endo Technologies

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Tissue Approximation Device	OCW	2	Contract manufacturer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Contract manufacturer	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Manufacturer	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Contract manufacturer	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Contract manufacturer	accessdata.fda.gov
Staple, Implantable	GDW	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	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
April 10, 2019	K182662	NAV PAK Needle, NIM NAV PAK Needle	PDQ	Substantially Equivalent	Boston Endo Surgical Tech,	accessdata.fda.gov
August 22, 2018	K180542	NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe	PDQ	Substantially Equivalent	Boston Endo Surgical Tech,	accessdata.fda.gov
October 25, 2013	K131058	BIPOLAR FORCEPS	GEI	Substantially Equivalent	Boston Endo-Surgical Technologies, Inc.	accessdata.fda.gov
August 23, 1994	K940750	INNERVISION,INC. LAPAROSCOPIC ELECTRODES	GEI	Substantially Equivalent	Innervision, Inc.	accessdata.fda.gov
June 13, 1994	K936304	ELECTROSURGICAL PENCIL	GEI	Substantially Equivalent	E & M Engineering, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 10, 2019. 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.