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FlexPointer 1.5

by Fiagon GmbH

FlexPointer 1.5, a multi-purpose stereotactic surgery system (FDA Class II; FDA product code PGW, Ear, Nose, And Throat Stereotaxic Instrument) made by Fiagon GmbH, was cleared under FDA 510(k) K150473 on 16 Apr 2015 and listed in FDA GUDID on 9 Aug 2016 (UDI-DI EFIAE0120041); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K150473

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEFIAE0120041 UDI-DI Date9 Aug 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK150473 Date16 Apr 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150473 decided 16 Apr 2015 Active
  • FDA GUDID UDI-DI EFIAE0120041 listed 9 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150473
  2. Listed FDA GUDID EFIAE0120041

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Multi-purpose stereotactic surgery system
Model / reference
1
Primary DI / UDI-DI
EFIAE0120041
510(k) Number
FDA product code
PGW
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Similar devices

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

Other devices from Fiagon GmbH

See all devices from Fiagon GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)