510(k) · Cleared

Cleared

Gore-Tex Dualmesh Emerge Plus Biomaterial

K032168510(k) SpecialCleared Aug 15, 200330-day reviewClass II21 CFR 878.3300

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

W. L. Gore & Associates, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Aug 15, 2003 as substantially equivalent to K022782 (W. L. Gore & Associates, Inc., 2002) and 4 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1997.

Decided: Aug 15, 2003
Review: 30 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K965038 (1997). 5 ancestors in all, the oldest K946106 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK965038 Gore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh…W. L. Gore & Associates, Inc. · 1997
1 generation backK981051 Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus…W. L. Gore & Associates, Inc. · 1998
This deviceK032168 Gore-Tex Dualmesh Emerge Plus BiomaterialW. L. Gore & Associates, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K965038	Gore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh Plus…	W. L. Gore & Associates, Inc.	1997	—
−1	K981051	Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus with Holes	W. L. Gore & Associates, Inc.	1998	—
0 (this device)	K032168	Gore-Tex Dualmesh Emerge Plus Biomaterial	W. L. Gore & Associates, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2000	1	0
2002	1	0

FIG. 1 — Lineage of K032168, 1997–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FTL device

#1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K022782	Dualmesh Emerge & Emerge Plus Biomaterial Summary page 2 …comparable features, materials of construction and intended use. o GORE-TEX DualMesh EMERGE and EMERGE PLUS Biomaterial (W.L. Gore & Assaciates, Inc., Flagstaff, AZ) — K022782 ¢ GORE-TEX DualMesh PLUS Biomaterial (W L. Gore & Associates, Inc., Flagstaff, A7) - KO00185, K981051, K965038, K946106 Labeli…	W. L. Gore & Associates, Inc.	2002	—
*	K000185	Gore-Tex Dualmesh Plus Biomaterial (1 MM & 2MM)	W. L. Gore & Associates, Inc.	2000	—
*	K981051	Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus with Holes Summary page 2 …PLUS Biomaterial (W.L. Gore & Assaciates, Inc., Flagstaff, AZ) — K022782 ¢ GORE-TEX DualMesh PLUS Biomaterial (W L. Gore & Associates, Inc., Flagstaff, A7) - KO00185, K981051, K965038, K946106 Labeling, packaging and sterilization of the GORE-TEX DualMesh EMERGE PLUS Biomaterial has not changed from th…	W. L. Gore & Associates, Inc.	1998	—
*	K965038	Gore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh Plus… Summary page 2 …material (W.L. Gore & Assaciates, Inc., Flagstaff, AZ) — K022782 ¢ GORE-TEX DualMesh PLUS Biomaterial (W L. Gore & Associates, Inc., Flagstaff, A7) - KO00185, K981051, K965038, K946106 Labeling, packaging and sterilization of the GORE-TEX DualMesh EMERGE PLUS Biomaterial has not changed from that of the…	W. L. Gore & Associates, Inc.	1997	—
*	K946106	Gore-Tex Dualmesh Plus Biomaterial Summary page 2 …(W.L. Gore & Assaciates, Inc., Flagstaff, AZ) — K022782 ¢ GORE-TEX DualMesh PLUS Biomaterial (W L. Gore & Associates, Inc., Flagstaff, A7) - KO00185, K981051, K965038, K946106 Labeling, packaging and sterilization of the GORE-TEX DualMesh EMERGE PLUS Biomaterial has not changed from that of the predicat…	W. L. Gore & Associates, Inc.	1995	—

Also cleared against K022782: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 5.3 years on median.
None of the 5 ancestors has a recall.
2 other devices also cite its predicate K022782.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	92	2	1,737
2008	23	114	1	1,569
2009	15	97	1	1,906
2010	18	132	12	2,175
2011	15	90	8	3,608
2012	12	213	2	14,700
2013	8	90	1	26,519
2014	11	70	3	2,683
2015	12	121	0	2,526
2016	3	186	0	2,417
2017	6	132	1	3,947
2018	12	105	1	11,893
2019	4	99	0	21,724
2020	5	138	1	18,819
2021	2	—	0	16,284
2022	6	195	0	11,439
2023	4	29	0	8,025
2024	2	—	0	8,565
2025	6	30	0	3,487
2026	2	—	0	—

What is it indicated for?

GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K032168 · printed Nov 3, 2026

Cite this page

510(k) Report. “K032168: Gore-Tex Dualmesh Emerge Plus Biomaterial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032168

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026