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Sentio 186002110S

by Medos International Sàrl

Sentio 186002110S is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K223438 on 10 Feb 2023 and listed in FDA GUDID since 1 Mar 2023 (UDI-DI 10705034560366), 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) K223438

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 Number10705034560366 UDI-DI Date1 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223438 Date10 Feb 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223438 decided 10 Feb 2023 Active
  • FDA GUDID UDI-DI 10705034560366 listed 1 Mar 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223438
  2. Listed FDA GUDID 10705034560366

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sentio
Generic name
Nerve-locating system probe, single-use
Model / Ref / Catalog
186002110S
Primary DI / UDI-DI
10705034560366
510(k) Number
FDA product code
PDQ
GMDN term
Nerve-locating system probe, single-use
Device class
Class II
Regulation number
874.1820
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)