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ProteXsure Safety Capsule System

by Starcap Medical, LLC ( Dba Prism Medical & Design)

510(k) K152597

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152597 Date8 Jun 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ProteXsure Safety Capsule System is a medical device designed for use in general hospital settings. It is intended to provide a safety mechanism for capsule-based procedures, though specific clinical indications are not detailed in the provided data.

The system is supplied as a non-sterile, reusable device and is not indicated for MRI environments. It is authorized under FDA 510(k) clearance K152597 with product code FMI, and was determined to be substantially equivalent to a predicate device. Storage and handling should follow manufacturer guidelines, though specific conditions are not stated in the data.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ProteXsure Safety Capsule System intended for?

    The ProteXsure Safety Capsule System is designed to provide a safety mechanism for capsule-based procedures in general hospital settings, though specific clinical indications are not detailed in the authorization data.

  • Is the ProteXsure Safety Capsule System sterile or non-sterile, and is it reusable?

    The system is supplied as a non-sterile device and is intended for reuse, meaning it must be cleaned and reprocessed according to manufacturer guidelines before each use.

  • What regulatory authorization does the ProteXsure Safety Capsule System have?

    The ProteXsure Safety Capsule System is authorized under FDA 510(k) clearance K152597, with product code FMI, and was determined to be substantially equivalent to a predicate device.

  • Can the ProteXsure Safety Capsule System be used in MRI environments?

    No, the device is not indicated for MRI environments, as explicitly stated in the device description, so it should not be used in or near magnetic resonance imaging systems.