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PointerShell Universal, PointerShell LS

by Fiagon GmbH

510(k) K160479

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160479↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK160479 Date23 Mar 2016ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160479 decided 23 Mar 2016 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
PGW
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 PointerShell Universal and PointerShell LS are Ear, Nose, and Throat Stereotaxic Instruments, designed for precise localization and guidance in ENT procedures. These devices feature adjustable, modular components to accommodate various anatomical landmarks, ensuring accurate targeting for diagnostic or therapeutic interventions in the head and neck region.

Supplied as reusable instruments, the PointerShell Universal and LS are intended for use in clinical settings such as operating rooms or procedural suites. They are classified as Class II devices under FDA regulations and comply with Medical Device Regulation (MDR) standards. Sterilization and maintenance protocols must adhere to manufacturer guidelines to ensure functionality and patient safety. No MRI safety information is specified, and their use is governed by the applicable FDA 510(k) clearance and MDR authorization

Devices cleared under K160479

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K160479
UDI-DISize and differences
PointerShell LS 1
Fiagon GmbH
1EFIAE0129061 —No longer on the market
PointerShell Universal 1
Fiagon GmbH
1EFIAE0129041 —No longer on the market
PointerShell Universal E012904
Fiagon GmbH
E012904 / E01290404260759930393 —On the market

Similar devices

Other devices filed under FDA product code PGW (Ear, Nose, And Throat Stereotaxic Instrument).

Other devices from Fiagon GmbH

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