PMT Mankind Lumbar-Peritoneal Shunt Model 1115-1

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

510(k) Number

K881616 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Progress Mankind Technology →

• What is the primary function of the PMT Mankind Lumbar-Peritoneal Shunt Model 1115-1?

  This device is a central nervous system shunt component specifically designed to facilitate the drainage of cerebrospinal fluid in clinical applications.

• What is the regulatory status of this shunt?

  The PMT Mankind Lumbar-Peritoneal Shunt Model 1115-1 is regulated as a Class II medical device under the neurology specialty and has received FDA 510(k) clearance for clinical use.

• Under which medical specialty is this device categorized?

  This device is categorized under the neurology specialty, as it is a component used for the management of cerebrospinal fluid within the central nervous system.