510(k) Report

FDA product code · General and plastic surgery

Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery

OWRClass II21 CFR 878.3300510(k) required1 decision since 20230 recalls

1 FDA decision since 2023. 510(k) reviews decided 2021–2025 took a median of 1,139 days (half between 1139 and 1139). No recall names this code.

For reinforcement of soft tissue where weakness exists in facial plastic surgery.

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 OWR 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 · OWR

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWR

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

Recalls per year · OWR

No recall names OWR since 2007.

Adverse event reports per year · OWR

No MAUDE report names OWR 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
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—
FIG. 1 — OWR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OWR? 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 OWR devices have the deepest lineage?

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

  • K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd. · 20232generations

What has FDA decided in OWR lately?

  • K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd. · 2023

The one OWR decision →

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