Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221435

FEI Number

1221435

Entity Name

ISPG, INC.

City/State/Country

Lakewood Ranch, FL, US

Establishment Address

10504 Technology Ter, Lakewood Ranch, FL 34211, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ISPG, Inc. (Owner Number: 1221435)

Owner / Operator Contact Address

10504 Technology Terr, Lakewood Ranch, FL 34211, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INJECTION CHIBA NEEDLE STYLET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2006-08-23
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2006-09-29
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-08-23

Official Correspondent

Maureen Young

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ISPG, 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
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221435. Last updated year: 2026. Please use registration number 1221435 when referencing this establishment in official correspondence.