Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019385708

FEI Number

3019385708

Entity Name

OBP SURGICAL CORPORATION

City/State/Country

Lawrence, MA, US

Establishment Address

360 Merrimack Street, BLDG 9, Lawrence, MA 01843, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

OBP SURGICAL CORPORATION (Owner Number: 10082003)

Owner / Operator Contact Address

360 merrimack street, BLDG 9, SUITE 470, Lawrence, MA 01843, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ONETRAC LXS FRAZIER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2022-11-14

Official Correspondent

KATE LESLIE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OBP SURGICAL CORPORATION

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019385708. Last updated year: 2026. Please use registration number 3019385708 when referencing this establishment in official correspondence.