Navigo™ Workstation FPRMC00039

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290016936346 UDI-DI	Date30 Aug 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Navigo™ Workstation
Generic Name: Rectal ultrasound navigational image processor
Model / Ref / Catalog: FPRMC00039

Primary DI / UDI-DI: 07290016936346
510(k) Number: K250664
FDA Product Code: LLZ, QTZ
GMDN Term: Rectal ultrasound navigational image processor

Device Class: Class II
Regulation Number: 892.2050
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

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Properties

Prescription Use
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No