510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Monofilament Biosyn Suture

K000037510(k) TraditionalCleared Mar 30, 200084-day reviewClass II21 CFR 878.4493Recalls 28

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 · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Mar 30, 2000 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 94 later devices descend from it. It has been recalled 28 times.

Decided
Mar 30, 2000
Review
84 days
Class
Class II
Product code
GAM
Recalls
28
Predicates
0

94 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2021: 7 descendants cleared2010: 2 descendants cleared2002: 1 descendant cleared2026: 8 descendants cleared2003: 1 descendant cleared2004: 2 descendants cleared2015: 5 descendants cleared2012: 7 descendants cleared2011: 1 descendant cleared2018: 4 descendants cleared2023: 5 descendants cleared2005: 1 descendant cleared2016: 5 descendants cleared2019: 4 descendants cleared2017: 6 descendants cleared2020: 5 descendants cleared2013: 6 descendants cleared2014: 8 descendants cleared2022: 7 descendants cleared2007: 1 descendant cleared2024: 4 descendants cleared2025: 3 descendants cleared200020052010201520202025
  1. This deviceK000037 Monofilament Biosyn SutureUnited States Surgical, A Division of Tyco Healthc · 2000
  2. Descendant · cites it directly · 48 of its ownK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
  3. Descendant · 2 generations on · 45 of its ownK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
  4. Descendant · 2 generations on · 44 of its ownK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
  5. Descendant · cites it directly · 43 of its ownK013671 L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002
  6. Descendant · 2 generations on · 29 of its ownK040477 MonodermSurgical Specialties Corp · 2004

Showing 5 of 94 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 22005: 12007: 12008: 12010: 22011: 12012: 72013: 62014: 82015: 52016: 52017: 62018: 42019: 42020: 52021: 72022: 72023: 52024: 42025: 32026: 8
2002high 8 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 94 · See all
  • K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP · 2008 · cites it directly48descendants
  • K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010 · 2 generations on45descendants
  • K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · 2 generations on44descendants
  • K013671L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002 · cites it directly43descendants
  • K040477MonodermSurgical Specialties Corp · 2004 · 2 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000037Monofilament Biosyn SutureUnited States Surgical, A Division of Tyco Healthc2000—
+1K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with…Tyco Healthcare Group LP200824
+2K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H2010—
+2K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA…Covidien, Formerly US Surgical A Divison of Tyco H201173
+1K013671L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc2002—
+2K040477MonodermSurgical Specialties Corp2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200420
200510
200710
200810
201020
201110
201270
201360
201480
201550
201650
201760
201840
201940
202050
202170
202270
202350
202440
202530
202680
FIG. 1 — Lineage of K000037, 2000–2026Source: 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 GAM? 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 GAM device

  1. #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (94)

See all 94

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP200848
K013671L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc200243
K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare201024
K211792StitchKitOrigami Surgical Inc .20211
K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic20260

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 18, 2019Class IIZ-1278-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1284-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1285-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1276-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1279-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1296-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1277-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1295-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1288-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1287-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1280-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1283-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1297-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1300-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1299-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1294-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1290-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1292-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1291-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1274-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1281-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1298-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1282-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1275-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1293-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1289-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Dec 18, 2019Class IIZ-1286-2020Equipment maintenanceThere is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
May 3, 2017Class IIZ-2544-2017Process controlPotential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

The 5 latest of 28 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K080898 (Tyco Healthcare Group LP, 2008) has gone furthest, with 48 descendants of its own.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAM

3in 2025

2007: 72008: 62009: 32010: 12011: 22012: 52013: 12014: 102015: 52016: 32017: 82018: 52019: 42020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007: 50 days median2008: 174 days median2009: 10 days median2012: 31 days median2014: 121 days median2015: 209 days median2016: 169 days median2017: 134 days median2018: 98 days median2019: 90 days median2020: 140 days median2025: 29 days median2026 (partial year): 131 days median
2007high 209 (2015) · low 10 (2009)2026

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

Recalls per year · GAM

1in 2024

2007: 102008: 12009: 62010: 32011: 62016: 12017: 12019: 12020: 442022: 42024: 12026 (partial year): 2
2007high 44 (2020) · low 0 (2012)2026

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

Adverse event reports per year · GAM

8,970in 2025

2007: 2742008: 1942009: 2872010: 5872011: 6372012: 8682013: 8982014: 1,4102015: 9352016: 1,1122017: 1,4992018: 2,2292019: 3,5642020: 3,4152021: 4,5062022: 4,8142023: 5,0702024: 7,2262025: 8,970
2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, 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
200775010274
200861741194
20093106287
20101—3587
20112—6637
20125310868
20131—0898
20141012101,410
201552090935
2016316911,112
2017813411,499
201859802,229
201949013,564
20203140443,415
20212—04,506
20222—44,814
20231—05,070
20242—17,226
202532908,970
202641312—

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 GAM

The GAM category page

  • K263073Fast Absorbing PGLARiverpoint Medical, LLC · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 2026
  • K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. · 2026
  • K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue…ETHICON, Inc. · 2025

https://510kreport.com/device/K000037 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000037: Monofilament Biosyn Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000037

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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