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g.Nautilus PRO 16-Channel-rX Sahara

by g.tec medical engineering GmbH

g.Nautilus PRO 16-Channel-rX Sahara (5212PRO) is a multiple physiological signal amplifier (FDA Class II) made by g.tec medical engineering GmbH, cleared under FDA 510(k) K171669 on 5 Jul 2017 and listed in FDA GUDID since 23 Nov 2017 (UDI-DI EBCI5212PRO0), active as of 23 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 23 Oct 2026

Documents

510(k) K171669

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 NumberEBCI5212PRO0 UDI-DI Date23 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171669 Date5 Jul 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171669 decided 5 Jul 2017 Active
  • FDA GUDID UDI-DI EBCI5212PRO0 listed 23 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171669
  2. Listed FDA GUDID EBCI5212PRO0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
g.Nautilus PRO
Generic name
Multiple physiological signal amplifier
Model / Ref / Catalog
16-Channel-rX Sahara, 5212PRO
Primary DI / UDI-DI
EBCI5212PRO0
510(k) Number
FDA product code
GXY, GWL
GMDN term
Multiple physiological signal amplifier
Device class
Class II
Regulation number
882.1320, 882.1835
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple physiological signal amplifier

Cleared under the same submission (K171669)

and 8 more cleared under K171669

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from g.tec medical engineering GmbH

See all devices from g.tec medical engineering GmbH →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)