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Ethicon Securestrap OPENSTRAP20

by Ethicon Inc.

Ethicon Securestrap OPENSTRAP20 is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K123114 on 5 Feb 2013 and listed in FDA GUDID since 23 Sep 2015 (UDI-DI 10705031202757), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K123114

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031202757 UDI-DI Date23 Sep 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123114 Date5 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123114 decided 5 Feb 2013 Active
  • FDA GUDID UDI-DI 10705031202757 listed 23 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123114
  2. Listed FDA GUDID 10705031202757

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ethicon Securestrap
Generic name
Open-surgery manual linear stapler, single-use
Model / Ref / Catalog
OPENSTRAP20
Primary DI / UDI-DI
10705031202757
510(k) Number
FDA product code
GDW
GMDN term
Open-surgery manual linear stapler, single-use
Device class
Class II
Regulation number
878.4750
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K123114)

Similar devices

Other devices filed under FDA product code GDW (STAPLE, IMPLANTABLE).

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

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