510(k) · Cleared
Recalled · Class II · 2020TroClose1200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gordian Surgical, Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Nov 17, 2016 as substantially equivalent to K123280 (Neosurgical, Ltd., 2013) and 1 other predicate after a 262-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 17, 2016
- Review
- 262 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011257 (2001). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011257 Endopath Non-Bladed Obturator Trocar System (5 MM)Ethicon Endo-Surgery, Inc. · 2001
- 2 generations backK112349 Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 1 generation backK130435 Versaport V2 Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- This deviceK160564 TroClose1200Gordian Surgical, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK253620 TroClose 1200Gordian Surgical, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253620TroClose 1200Gordian Surgical, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM) | Ethicon Endo-Surgery, Inc. | 2001 | — |
| −2 | K112349 | Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 6 |
| −1 | K130435 | Versaport V2 Bladeless Optical Trocar | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| 0 (this device) | K160564 | TroClose1200 | Gordian Surgical, Ltd. | 2016 | — |
| +1 | K253620 | TroClose 1200 | Gordian Surgical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 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 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K123280 | Neoclose Hasson, Neoclose UniversalSummary page 4…R §878.4493 Product Code: GAM (absorbable PGLA suture) , GCJ (Endoscope and accessories) Predicate Devices Primary Predicate Device- Closure Device- neoClose® (K123280) (21 CFR §876.1500, product code GCJ) Secondary Predicate Device- Trocar- Versaport™ V2 Bladeless Trocar (K130435) (21 CFR §876.… | 2013 |
| * | K130435 | Versaport V2 Bladeless Optical TrocarSummary page 4…Primary Predicate Device- Closure Device- neoClose® (K123280) (21 CFR §876.1500, product code GCJ) Secondary Predicate Device- Trocar- Versaport™ V2 Bladeless Trocar (K130435) (21 CFR §876.1500, product code GCJ). Intended Use / Indications for Use The TroClose1200™ bladeless trocar is intended for… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253620 | TroClose 1200 | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2020 | Class II | Z-0398-2021 | Process control | Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K253620 (Gordian Surgical, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123280.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
The TroClose1200™ bladeless trocar is intended for use in a variety of gynecologic, general and urologic endoscopic procedures to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic/ laparoscopic surgery.
The trocar may be used with or without visualization for primary and secondary insertions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160564: TroClose1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160564
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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