Ethicon Securestrap Open Absorbable Strap Fixation Device

510(k) Number

K123114 ↗

FDA product code

GDW

FDA applicant

ETHICON, Inc.

Device class

Class II

Regulation

21 CFR Part 878.4750

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code GDW (Staple, Implantable).

• ENDOANCHOR AND OPENANCHOR by Ethicon Endo-Surgery, LLC
• PRECISE BARND PI DISPOSABLE SURGICAL STAPLES by 3M Medical Products Group
• ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm by Ethicon Endo-Surgery, LLC
• Signia SIGSBCHGR by Covidien LP
• OPTIFIX ABSORBABLE FIXATION SYSTEM by C. R. Bard, Inc.
• GIA Auto Suture Stapler with DST Series Technology by Covidien llc
• HAND STC, MODEL 60MM by Niti Medical Technologies, Ltd.
• DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS by Covidien, Formerly US Surgical A Divison of Tyco H
• Endo Linear Cutter Stapler CEAB-45 by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO.,LTD
• Circular Stapler FCSME32 by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO.,LTD

• Stratafix SXPN1B402

  Class II

  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B413

  Class II

  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B409

  Class II

  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

• Stratafix SXPN1B403

  Class II

  FDA 510(k) K253572 Active Cleared 27 Mar 2026 GUDID on market

See all devices from Ethicon Inc. →