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Data / Medical devices / Canada / Stryker Endoscopy

Stryker Endoscopy: FDA-registered device maker in Toronto Ontario, Canada, 5 510(k) clearances

Stryker Endoscopy is registered with the FDA (registration 3015439135) in Toronto Ontario, Canada. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 31, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3015439135
Address
50 Wellington Street East Suite 400, Toronto Ontario, Canada, M5E 1C8
Owner or operator
STRYKER CORP. (1811755)
Roles
Specification developer
First device listed
December 15, 1992
Registered through
2027
Brand names listed
Hydro Pole Mount, IV Pole, Infusion Stand, MM1000 MOLLI Introducer (8cm, 14G) and MOLLI Marker, MM1000 MOLLI Marker 8cm w/ Introducer, MM1000 MOLLI Marker and Introducer (8 cm), MOLLI 2, MP2001 MOLLI 2 Wand and more

Devices it lists

DeviceProduct codeClassRoleSource
Endoscopic Magnetic Retriever, ExemptPTQ2Specification developeraccessdata.fda.gov
Marker, Radiographic, ImplantableNEU2Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 31, 2025K253888MOLLI 2 SystemNEUSubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
September 26, 2024K234149MOLLI 2 SystemNEUSubstantially EquivalentMolli Surgical, Inc.accessdata.fda.gov
September 25, 2024K240042MOLLI 2 SystemNEUSubstantially EquivalentMolli Surgical, Inc.accessdata.fda.gov
October 26, 2023K231579MOLLI 2NEUSubstantially EquivalentMolli Surgical, Inc.accessdata.fda.gov
January 18, 2023K223107MOLLI 2NEUSubstantially EquivalentMolli Surgical, Inc.accessdata.fda.gov

Compare with other makers

Updated December 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.