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Neurological or Crani Trays (Packs)

by Associated Medical Products Co.

510(k) K932221

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 NumberK932221 Date19 Mar 1997ClearedStatusActive

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  • Withdrawn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
LRO
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a neurological or craniotomy tray (pack), which is a collection of instruments and supplies intended for use in neurological or craniotomy procedures. It is designed to support surgical interventions involving the skull and brain by providing necessary tools in a pre-assembled configuration.

The tray is supplied as a pack for use in clinical settings such as operating rooms. It is intended for single-use or reusable application depending on the specific components included, and its sterility status and MRI safety are determined by the individual components within the pack. The device was cleared through the FDA 510(k) process under K932221 with product code LRO, and is authorized for distribution in the United States.

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