Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015439135

FEI Number

3015439135

Entity Name

Stryker Endoscopy

City/State/Country

Toronto Ontario, CA

Establishment Address

50 Wellington Street East, Suite 400, Toronto Ontario M5E 1C8, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MP2015A MOLLI OncoPen MT2001 MOLLI 2 Tablet MP2025S MOLLI OncoPen Prime MP2040S MOLLI OncoPen Elite MM1000 MOLLI Introducer (8cm, 14G) and MOLLI Marker MP2001 MOLLI 2 Wand MP2015A MOLLI OncoPen MS-00009 MOLLI Introducer (12cm, 14G) and MOLLI Marker MT2001 MOLLI 2 Tablet MM1000 MOLLI Marker 8cm w/ Introducer MOLLI 2 MS-00009 MOLLI Marker 12 cm w/ Introducer MM1000 MOLLI Marker and Introducer (8 cm) MS-00009 MOLLI Marker and Introducer (12 cm) MP2001 Molli 2 Wand MT2001 Molli 2 Tablet MP2015A Molli OncoPen IV Pole THC5 Stand TPS2 Stand Infusion Stand MS -00017 MOLLI Pole Clamp Hydro Pole Mount RM0112 re.markable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-10-29
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-01-13
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-08-14
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-10-29
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	1992-12-15
PTQ	Endoscopic Magnetic Retriever, Exempt	Gastroenterology, Urology	Class 2	876.1500	2024-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

April Malmborg Business: Stryker Endoscopy Email: april.malmborg@stryker.com Phone: (408) 4093115

Related Public Records

Same Entity

STRYKER CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260108	Stryker Endoscopy	L12 LED Light Source with AIM	2026-02-12

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3015924373	AUSA Medical Device Pvt Ltd	Bangalore Karnataka, IN
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015439135. Last updated year: 2026. Please use registration number 3015439135 when referencing this establishment in official correspondence.