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Teleflex IPN928805

by Teleflex Incorporated

Ref ST19

Teleflex IPN928805 (ST19) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 08019020000000000000272KT), cleared under FDA 510(k) K200517 on 9 Apr 2020 and listed in FDA GUDID since 31 Jul 2026 (UDI-DI 14026704921741), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200517

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number14026704921741 UDI-DI Date31 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08019020000000000000272KT Basic UDI-DI 14026704921741UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK200517 Date9 Apr 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000272KT registered 6 Jul 2026 Active
  • FDA 510(k) K200517 decided 9 Apr 2020 Active
  • FDA GUDID UDI-DI 14026704921741 listed 31 Jul 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200517
  2. Registered EUDAMED 08019020000000000000272KT
  3. Listed FDA GUDID 14026704921741

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Titan SGS™ Standard Trocar™ Device EUDAMED
Teleflex GUDID
Generic name
Laparoscopic trocar blade, single-use
Device name
Titan SGS Standard Trocar Device
Model / Ref / Catalog
ST19, IPN928805
Primary DI / UDI-DI
14026704921741
Basic UDI-DI
08019020000000000000272KT
510(k) Number
FDA product code
GCJ
EMDN code
K01010101 Trocar standard, single-use
GMDN term
Laparoscopic trocar blade, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ST19
GUDID
IPN928805
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Cleared under the same submission (K200517)

Similar devices in this category

Other devices filed under TROCAR STANDARD, SINGLE-USE.

Other devices from Teleflex Incorporated

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)