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Ps Medical Ventriculostomy Kit

by Pudenz-Schulte Medical Research Corp.

510(k) K915546

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK915546 Date30 Dec 1991ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2768-2026 FDA Class II initiated 17 Jun 2026

    Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.

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  • Withdrawn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
HBG
Device Class
Class II
Regulation
21 CFR Part 882.4300
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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