510(k) Report

510(k) · Cleared

Recalled · 2010

Coated Surgipro (TM) Polypropylene Surgical Mesh

K915526510(k) TraditionalCleared May 29, 1992171-day reviewClass II21 CFR 878.3300Recalls 1

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

United States Surgical, A Division of Tyco Healthc · FTL Mesh, Surgical, Polymeric

Cleared on May 29, 1992 after a 171-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
May 29, 1992
Review
171 days
Class
Class II
Product code
FTL
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared1990200020102020
  1. This deviceK915526 Coated Surgipro (TM) Polypropylene Surgical MeshUnited States Surgical, A Division of Tyco Healthc · 1992
  2. Descendant · cites it directly · 0 of its ownK073164 Ivs Tunneller DevicesCovidien UK Manufacturing, Ltd. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K073164Ivs Tunneller DevicesCovidien UK Manufacturing, Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915526Coated Surgipro (TM) Polypropylene Surgical MeshUnited States Surgical, A Division of Tyco Healthc1992—
+1K073164Ivs Tunneller DevicesCovidien UK Manufacturing, Ltd.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K915526, 1992–2008Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073164Ivs Tunneller DevicesCovidien UK Manufacturing, Ltd.20080

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 15, 2010Not classifiedZ-1009-2011Packaging process controlSterility compromised due to breach in sterile barrier

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K073164 (Covidien UK Manufacturing, Ltd., 2008) has gone furthest, with 0 descendants of its own.

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

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—

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in FTL

The FTL category page

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https://510kreport.com/device/K915526 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915526: Coated Surgipro (TM) Polypropylene Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915526

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026