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Ethicon Securestrap STRAP25R

by Ethicon Inc.

Ref STRAP25RModel ETHICON SECURESTRAP

Ethicon Securestrap STRAP25R is a device classified as Class III in the EU and Class II in the US made by Ethicon Inc., registered in EUDAMED on 14 Nov 2025 (Basic UDI-DI 0705031a000073X), cleared under FDA 510(k) K093845 on 7 Apr 2010 and listed in FDA GUDID since 24 Jan 2024 (UDI-DI 10705031470552), active as of 7 Nov 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093845

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705031a000073X Basic UDI-DI 10705031470552UDI-DIDate14 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031470552 UDI-DI Date24 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093845 Date7 Apr 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705031a000073X registered 14 Nov 2025 Active
  • FDA 510(k) K093845 decided 7 Apr 2010 Active
  • FDA GUDID UDI-DI 10705031470552 listed 24 Jan 2024 Listed

Recalls

1 recall · FDA

    • Terminated Z-1260-2011 FDA Unclassified (pre-2012) initiated 29 Dec 2010

    The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.

Timeline

4 dated events

  1. Cleared FDA 510(k) K093845
  2. Recall initiated FDA recalls Z-1260-2011
  3. Listed FDA GUDID 10705031470552
  4. Registered EUDAMED 0705031a000073X

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  • Withdrawn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
Ethicon Securestrap
Generic name
Endoscopic manual linear stapler
Device name
ETHICON SECURESTRAP Absorbable Strap Fixation Device
Model / Ref / Catalog
STRAP25R, ETHICON SECURESTRAP
Primary DI / UDI-DI
10705031470552
Basic UDI-DI
0705031a000073X
510(k) Number
FDA product code
GDW
EMDN code
H020399 Staplers, videosurgery - other
GMDN term
Endoscopic manual linear stapler
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4750
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class III 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 manual linear stapler

Cleared under the same submission (K093845)

Similar devices in this category

Other devices filed under STAPLERS FOR VIDEOSURGERY.

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)