FDA 510(k)

ProteXsure Safety Capsule System

K-Number: K152597 · 2016-06-08

ApplicantStarcap Medical, LLC ( Dba Prism Medical & Design)

Decision Date2016-06-08

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ProteXsure Safety Capsule System is a medical device manufactured by Starcap Medical, LLC ( Dba Prism Medical & Design). It received FDA 510(k) clearance on 2016-06-08 under approval number K152597. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProteXsure Safety Capsule System?

ProteXsure Safety Capsule System is a medical device that received FDA 510(k) clearance on 2016-06-08. It is manufactured by Starcap Medical, LLC ( Dba Prism Medical & Design). The 510(k) number is K152597.

When was ProteXsure Safety Capsule System approved by the FDA?

ProteXsure Safety Capsule System received FDA 510(k) clearance on 2016-06-08, under approval number K152597.

What company makes ProteXsure Safety Capsule System?

ProteXsure Safety Capsule System is manufactured by Starcap Medical, LLC ( Dba Prism Medical & Design).

What is the FDA product code for ProteXsure Safety Capsule System?

The FDA product code for ProteXsure Safety Capsule System is FMI.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.