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Teleflex IPN928801

by Teleflex Incorporated

Ref SBC

Teleflex IPN928801 (SBC) is a device classified as Class I in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 08019020000000000000276L3), cleared under FDA 510(k) K210278 on 28 Apr 2021 and listed in FDA GUDID since 13 May 2025 (UDI-DI 14026704921789), 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) K210278

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000276L3 Basic UDI-DI 14026704921789UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704921789 UDI-DI Date13 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210278 Date28 Apr 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000276L3 registered 6 Jul 2026 Active
  • FDA 510(k) K210278 decided 28 Apr 2021 Active
  • FDA GUDID UDI-DI 14026704921789 listed 13 May 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K210278
  2. Listed FDA GUDID 14026704921789
  3. Registered EUDAMED 08019020000000000000276L3

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  • Withdrawn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 Bailout Key EUDAMED
Teleflex GUDID
Generic name
Endoscopic motorized cutting stapler, single-use
Model / Ref / Catalog
SBC, IPN928801
Primary DI / UDI-DI
14026704921789
Basic UDI-DI
08019020000000000000276L3
510(k) Number
FDA product code
GDW
EMDN code
H020301040102 Single patient straight linear staplers with blade for laparoscopy
GMDN term
Endoscopic motorized cutting stapler, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4750
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
SBC
GUDID
IPN928801
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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

Category: Endoscopic motorized cutting stapler, single-use

Cleared under the same submission (K210278)

and 3 more cleared under K210278

Similar devices in this category

Other devices filed under SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

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