LACEY MANUFACTURING COMPANY LLC

FDA Device Registration & Listing · BRIDGEPORT, CT, US · Registration 1218017

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1218017
FEI Number
1218017
Entity Name
LACEY MANUFACTURING COMPANY LLC
City/State/Country
BRIDGEPORT, CT, US
Establishment Address
1146 Barnum Ave, BRIDGEPORT, CT 06610, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PARAGON MEDICAL, INC. (Owner Number: 1218017)
Owner / Operator Contact Address
7800 Equitable Dr, --, Eden Prairie, MN 55344, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Boston Endo Technologies Boston Endo Technologies BEST Bipolar Forceps

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2019-04-11
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2013-01-26
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2012-12-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-04-05
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2012-04-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-12-10
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2026-02-03
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-24
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2016-06-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-12-06
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2012-12-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-03-02
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2018-03-02
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2026-02-03

Official Correspondent

Rob Macnamara

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PARAGON MEDICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011445359 Paragon Medical - Southington Southington, CT, US
3007544634 Paragon Medical - Mansfield, Bridgemedica Mansfield, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K082659 Covidien Lp, Formerly Registered AS United States MODIFIED ENDO STICH 2008-09-19
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09
K131705 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 2013-07-01
K103263 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY 2010-11-22
K130717 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RELOAD 2013-04-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2021 N/A 2
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021 N/A 2
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218017. Last updated year: 2026. Please use registration number 1218017 when referencing this establishment in official correspondence.
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