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Teligen 186000000S

by Medos International Sàrl

Teligen 186000000S is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K233254 on 14 Jun 2024 (3 earlier submissions) and listed in FDA GUDID since 1 Mar 2023 (UDI-DI 10705034560359), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233254 Date14 Jun 2024DecidedStatusActive
United StatesGUDID listing Number10705034560359 UDI-DI Date1 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233254 decided 14 Jun 2024 Active· +3 more in the status table
  • FDA GUDID UDI-DI 10705034560359 listed 1 Mar 2023 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K213978
  2. Cleared FDA 510(k) K223108
  3. Cleared FDA 510(k) K223438
  4. Listed FDA GUDID 10705034560359
  5. Cleared FDA 510(k) K233254

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Teligen
Generic name
Orthopaedic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
186000000S
Primary DI / UDI-DI
10705034560359
510(k) Number
FDA product code
PDQ, LXH, HRX, GAD, OLO
GMDN term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device class
Class II
Regulation number
874.1820, 888.4540, 888.1100, 878.4800, 882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

Cleared under the same submission (K213978)

and 1 more cleared under K213978

Cleared under the same submission (K223108)

Similar devices

Other devices filed under FDA product code PDQ (Neurosurgical nerve locator).

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

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