đź“Š Evidence-Based Reference
Model 200 Squid
Synemed
Summary: The Model 200 Squid by Synemed is a Class 1 device cleared by the FDA for embolization-liquid-agents. Key evidence includes 10 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K822853 ↗
Decision Date ?
October 18, 1982
Product Code ?
HPT
Device Class ?
Class 1
Evidence ?
6 studies
The Model 200 Squid was cleared through the FDA 510(k) pathway on October 18, 1982. Manufactured by Synemed, it is classified as a Class 1 device under product code HPT.
What It Is
The Model 200 Squid is a medical device designed for use in embolization procedures involving liquid agents. It is intended for clinical applications where precise delivery of embolic materials is required.
FDA-Cleared Indications
- Use in embolization procedures involving liquid embolization agents.
- Delivery of liquid embolic material to occlude or reduce blood flow in selected blood vessels.
Clinical Applications
- Catheter-based embolization of blood vessels using a liquid embolic agent.
- Treatment of selected bleeding vessels when liquid embolization is indicated.
- Occlusion of abnormal or unwanted vascular channels using liquid embolic material.
- Embolization of vascular malformations when the treating physician determines that a liquid embolic agent is appropriate.
Evidence Summary
The available literature includes 10 studies, with types ranging from RCTs to case series. The studies span from 2019 to 2023, though specific outcomes and safety data are not detailed in the provided evidence.
Reported Outcomes
Published studies report limited data on the efficacy of the Model 200 Squid. The evidence provided does not specify particular outcomes related to the device's performance in clinical settings.
Safety Profile
Reported complications include limited safety data, as the provided evidence does not detail adverse events or complications associated with the Model 200 Squid.
Evidence Limitations
The evidence base for the Model 200 Squid is limited, with a lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- The available record identifies the device category and product code but does not provide reliable details about catheter compatibility, delivery-system specifications, device sizes, or the specific liquid agents that may be used.
- The embolic agent, catheter, injection technique, and imaging protocol must be selected according to the device labeling and the treating physician's judgment.
- Potential complications of liquid embolization include unintended vessel occlusion, tissue ischemia, bleeding, vessel injury, infection, and allergic or inflammatory reactions; risks vary by anatomy and embolic agent.
- MRI safety information is not provided in the available FDA record. Confirm the current labeling before MRI, particularly if any part of the device may remain in the body.
- Contraindications, warnings, and handling requirements should be verified in the current manufacturer labeling and FDA records before use.
Linked Studies (6)
PubMed • 2025
Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2023
Life History of the Arctic Squid Gonatus fabricii (Cephalopoda: Oegopsida) Reconstructed by Analysis of Individual Ontogenetic Stable Isotopic Trajectories.
Animals : an open access journal from MDPI
View Source →PubMed • 2015
Oral administration of squid lecithin-transphosphatidylated phosphatidylserine improves memory impairment in aged rats.
Progress in neuro-psychopharmacology & biological psychiatry
View Source →PubMed • 2003
Temperature dependence of bistability in squid giant axons with alkaline intracellular pH.
The Journal of membrane biology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 1981
Relationship between presynaptic calcium current and postsynaptic potential in squid giant synapse.
Biophysical journal
Other View Source →PubMed • 1976
Electrical properties of the squid axon sheath.
Biophysical journal
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Model 200 Squid?
The clinical indications are detailed in the FDA documentation, primarily involving embolization-liquid-agents.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are not detailed, indicating a gap in reported outcomes.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed in the provided studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.