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Compass International FP-10

by Compass International

Compass International FP-10 is a Class II device made by Compass International, listed in FDA GUDID since 22 Sep 2016 (UDI-DI B169FP100), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB169FP100 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Compass International
Generic name
Neurological stereotactic surgery system
Model / Ref / Catalog
FP-10
Primary DI / UDI-DI
B169FP100
FDA product code
HAW
GMDN term
Neurological stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

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Properties

  • Sterilise before use
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)