510(k) Report

FDA product code · General and plastic surgery

Mesh, Surgical, Collagen, Staple Line Reinforcement

OXEClass II21 CFR 878.3300510(k) required4 decisions since 20020 recalls

4 FDA decisions since 2002. No recall names this code. The most-cited predicate is K030879, named by 4 later devices.

For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of OXE at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OXE

1in 2017

2016: 12017: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OXE

Too few OXE 510(k)s in any year since 2007 to give a median.

Recalls per year · OXE

No recall names OXE since 2007.

Adverse event reports per year · OXE

No MAUDE report names OXE since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OXE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OXE? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OXE devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K030879Veritas Collagen MatrixSynovis Surgical Innovations · 20034cite it
  • K022044Surgisis Staple Line ReinforcementCook Biotech, Inc. · 20022cite it
  • K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated · 20171cites it

Which OXE devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated · 201710generations
  • K153364Kerecis SecureMeshKerecis Limited · 20168generations
  • K022044Surgisis Staple Line ReinforcementCook Biotech, Inc. · 20023generations

What has FDA decided in OXE lately?

  • K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017
  • K153364Kerecis SecureMeshKerecis Limited · 2016
  • K030879Veritas Collagen MatrixSynovis Surgical Innovations · 2003
  • K022044Surgisis Staple Line ReinforcementCook Biotech, Inc. · 2002

All 4 OXE decisions →

Related product codes

Other codes under 21 CFR 878.3300.

JDJ Mesh, Surgical, Acetabular, Hip, ProsthesisQUW Mesh, Surgical, Non-Resorbable, Orthopedics…OWY Mesh, Surgical, Collagen, Orthopaedics…PIJ Collagen Surgical Mesh Containing DrugsOWW Mesh, Surgical, Absorbable, Orthopaedics…OQL Mesh, Surgical, Deployment BalloonOWR Mesh, Surgical, Non-Absorbable, Facial…PAH Mesh, Surgical, Synthetic, Urogynecologic, For…OWV Mesh, Surgical, Collagen, Diaphragmatic HerniaOOD Surgical FilmMCA Tape, Surgical, InternalOTO Mesh, Surgical, Synthetic, Urogynecologic, For…