Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012998149

FEI Number

3012998149

Entity Name

LEXINGTON MEDICAL, INC.

City/State/Country

Bedford, MA, US

Establishment Address

23 Crosby Drive, Bedford, MA 01730, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Lexington Medical, Inc. (Owner Number: 10054419)

Owner / Operator Contact Address

23 Crosby Drive, Bedford, MA 01730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182380

PMA Number

N/A

All Registered Proprietary Names

AEON Retrieval Bag AEON Endoscopic Stapler AEON Endoscopic Stapler AEON Endoscopic Stapler AEON Endoscopic Powered Stapler AEON Endoscopic Stapler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-05-16
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-10-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-10-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-10-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-11-20
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-10-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-05-13
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-05-13
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-10-05

Official Correspondent

Marc Jin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lexington Medical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0070-2019	COVIDIEN LLC	2	EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012998149. Last updated year: 2026. Please use registration number 3012998149 when referencing this establishment in official correspondence.