Endobutton Continuous Loop

510(k) Number

K980155 ↗

FDA product code

GAT

Device class

Class II

Regulation

21 CFR Part 878.5000

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 GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

• FORCE FIBER IPN000933 SMK100101S by TELEFLEX INCORPORATED
• SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 by Sorin Group USA, Inc.
• Arthrex® AR-7276 by Arthrex, Inc.
• 'cottony' II TAPE, PLEDGETS by Teleflex Medical, LLC
• HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED by RIVERPOINT MEDICAL LLC
• Arthrex® AR-1530DS by Arthrex, Inc.
• PERMATAPE by MEDOS INTERNATIONAL SARL
• GRAMS POLYESTER NONABSORBABLE SUTURE by Gramsmed, LLC
• AXYAFLEX POLYESTER SUTURE by Axya Medical, Inc.
• TI-CRON AND DACRON SUTURES by Davis & Geck, Inc.

• Real Intelligence ROB30801

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• Real Intelligence ROB30007

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-01

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-04

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

See all devices from Smith & Nephew, Inc. →