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COMPASS Stereotactic System PION-20

by Compass International

COMPASS Stereotactic System PION-20 is a Class II device made by Compass International, cleared under FDA 510(k) K871046 on 8 May 1987 and listed in FDA GUDID since 29 Jan 2026 (UDI-DI 00860009258112), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K871046

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009258112 UDI-DI Date29 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK871046 Date8 May 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K871046 decided 8 May 1987 Active
  • FDA GUDID UDI-DI 00860009258112 listed 29 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K871046
  2. Listed FDA GUDID 00860009258112

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
COMPASS Stereotactic System
Generic name
Neurological stereotactic surgery system
Model / Ref / Catalog
PION-20
Primary DI / UDI-DI
00860009258112
510(k) Number
FDA product code
HAW
GMDN term
Neurological stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Similar devices

Other devices filed under FDA product code HAW (Neurological Stereotaxic Instrument).

Other devices from Compass International

See all devices from Compass International →

Properties

  • Sterilise before use
  • Prescription use
Other properties (13, all answered No)