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Ethicon Securestrap OPSTRAP20R

by Ethicon Inc.

Ref OPSTRAP20RModel ETHICON SECURESTRAP OPEN

Ethicon Securestrap OPSTRAP20R 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 0705031a011664T), cleared under FDA 510(k) K123114 on 5 Feb 2013 and listed in FDA GUDID since 13 Mar 2024 (UDI-DI 10705031470569), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123114

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 Number0705031a011664T Basic UDI-DI 10705031470569UDI-DIDate14 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705031470569 UDI-DI Date13 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123114 Date5 Feb 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705031a011664T registered 14 Nov 2025 Active
  • FDA 510(k) K123114 decided 5 Feb 2013 Active
  • FDA GUDID UDI-DI 10705031470569 listed 13 Mar 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123114
  2. Listed FDA GUDID 10705031470569
  3. Registered EUDAMED 0705031a011664T

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  • Withdrawn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 Open EUDAMED
Ethicon Securestrap GUDID
Generic name
Open-surgery manual linear stapler, single-use
Device name
ETHICON SECURESTRAP Open Absorbable Strap Fixation Device
Model / Ref / Catalog
OPSTRAP20R, ETHICON SECURESTRAP OPEN
Primary DI / UDI-DI
10705031470569
Basic UDI-DI
0705031a011664T
510(k) Number
FDA product code
GDW
EMDN code
H020299 Staplers for open surgery - other
GMDN term
Open-surgery manual linear stapler, single-use
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: Open-surgery manual linear stapler, single-use

Cleared under the same submission (K123114)

Similar devices in this category

Other devices filed under STAPLERS, OPEN SURGERY.

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)