510(k) Report

510(k) · Cleared

Cleared

Universal Surgical Mesh, Model 100

K070018510(k) TraditionalCleared Apr 27, 2007114-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

Generic Medical Device, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Apr 27, 2007 as substantially equivalent to K962530 (ETHICON, Inc., 1996) after a 114-day review. Its family tree reaches back 1 generation to 1996.

Decided
Apr 27, 2007
Review
114 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K962530 (1996). No later device cites it as a predicate yet.

K962530 · Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh · ETHICON, Inc. · 19961996199820002002200420062008
K962530 · Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh · ETHICON, Inc. · 19960
  1. Root · 1 generation backK962530 Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshETHICON, Inc. · 1996
  2. This deviceK070018 Universal Surgical Mesh, Model 100Generic Medical Device, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962530Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshETHICON, Inc.1996—
0 (this device)K070018Universal Surgical Mesh, Model 100Generic Medical Device, Inc.2007—
FIG. 1 — Lineage of K070018, 1996–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K962530Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh
Summary page 1
…al Surgical Mesh Common Name: Surgical Mesh Classification Name: Surgical Mesh Class II: General & Plastic Surgery 21 CFR 878.3300, Product Code FTL. Predicate Devices: K962530- PROLENE Polypropylene Mesh Nonabsorbable Synthetic Manufactured by: Ethicon, Inc. Somerville, New Jersey 08876-0151 510(k) Clas…
ETHICON, Inc.1996—

Also cleared against K962530: 5 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?

  • Its one ancestor has no recall.
  • 5 other devices also cite its predicate K962530.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
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

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

The Universal Surgical Mesh is indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Indications for use as stated in the FDA summary.

Also cleared against K962530

5 other devices cite the same predicate.

  • K180829PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System…ETHICON, Inc. · 2018
  • K053158Optilene Mesh LPAesculap, Inc. · 2006
  • K052864Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc. · 2005
  • K023237Xylos Surgical MeshXylos Corporation · 2003
  • K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000

More from Generic Medical Device, Inc.

4 FDA decisions under this applicant name. See the company

  • K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011
  • K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 20092 recalls
  • K063429GMD Universal Circumcision Clamp, Model 200Generic Medical Device, Inc. · 2007

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K070018 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070018: Universal Surgical Mesh, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070018

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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